{"id":5027,"date":"2025-11-03T18:58:47","date_gmt":"2025-11-03T15:58:47","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=5027"},"modified":"2025-11-03T19:01:49","modified_gmt":"2025-11-03T16:01:49","slug":"biologics-license-application-bla","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/hi\/biologics-license-application-bla\/","title":{"rendered":"\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f): 1\u091f\u0940\u092a\u0940135\u091f\u0940 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u0947 \u0932\u093f\u090f \u090f\u0915 \u0938\u0902\u092a\u0942\u0930\u094d\u0923 \u092e\u093e\u0930\u094d\u0917\u0926\u0930\u094d\u0936\u093f\u0915\u093e"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u090f\u092a\u094d\u0932\u0940\u0915\u0947\u0936\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0921\u094d\u092f\u0942\u091a\u0947\u0928 \u092e\u0938\u094d\u0915\u0941\u0932\u0930 \u0921\u093f\u0938\u094d\u091f\u094d\u0930\u0949\u092b\u0940 (\u0921\u0940\u090f\u092e\u0921\u0940) \u0915\u0947 \u0932\u093f\u090f \u0928\u090f \u091c\u0948\u0935\u093f\u0915 \u0909\u092a\u091a\u093e\u0930\u094b\u0902 \u0915\u094b \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0924\u0915 \u092a\u0939\u0941\u0902\u091a\u093e\u0928\u0947 \u092e\u0947\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u092d\u0942\u092e\u093f\u0915\u093e \u0928\u093f\u092d\u093e\u0924\u093e \u0939\u0948\u0964.<\/strong> \u092c\u0940\u090f\u0932\u090f \u090f\u0915 \u0914\u092a\u091a\u093e\u0930\u093f\u0915 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u0915\u0930\u0923 \u0939\u0948 \u091c\u094b \u0915\u094b\u0908 \u091c\u0948\u0935 \u092a\u094d\u0930\u094c\u0926\u094d\u092f\u094b\u0917\u093f\u0915\u0940 \u092f\u093e \u0926\u0935\u093e \u0915\u0902\u092a\u0928\u0940 \u0905\u092e\u0947\u0930\u093f\u0915\u0940 \u0916\u093e\u0926\u094d\u092f \u090f\u0935\u0902 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 (FDA) \u0915\u094b \u0915\u093f\u0938\u0940 \u091c\u0948\u0935\u093f\u0915 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0947 \u0935\u093f\u092a\u0923\u0928 \u0939\u0947\u0924\u0941 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0939\u0947\u0924\u0941 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u0930\u0924\u0940 \u0939\u0948\u0964 \u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0915\u0947 \u0938\u0902\u0926\u0930\u094d\u092d \u092e\u0947\u0902, \u091c\u0939\u093e\u0901 \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940, \u090f\u0915\u094d\u0938\u0949\u0928-\u0938\u094d\u0915\u093f\u092a\u093f\u0902\u0917 \u0926\u0935\u093e\u090f\u0901 \u0914\u0930 \u092e\u094b\u0928\u094b\u0915\u094d\u0932\u094b\u0928\u0932 \u090f\u0902\u091f\u0940\u092c\u0949\u0921\u0940 \u091c\u0948\u0938\u0947 \u0905\u0924\u094d\u092f\u093e\u0927\u0941\u0928\u093f\u0915 \u0909\u092a\u091a\u093e\u0930 \u0924\u0947\u091c\u093c\u0940 \u0938\u0947 \u0935\u093f\u0915\u0938\u093f\u0924 \u0939\u094b \u0930\u0939\u0947 \u0939\u0948\u0902, \u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u094b \u0938\u092e\u091d\u0928\u093e \u0906\u0935\u0936\u094d\u092f\u0915 \u0939\u0948\u0964 \u092f\u0939 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u0930\u0924\u093e \u0939\u0948 \u0915\u093f \u0906\u0936\u093e\u091c\u0928\u0915 \u0909\u092a\u091a\u093e\u0930 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0924\u0915 \u092a\u0939\u0941\u0901\u091a\u0928\u0947 \u0938\u0947 \u092a\u0939\u0932\u0947 \u0938\u0941\u0930\u0915\u094d\u0937\u093e, \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0914\u0930 \u0917\u0941\u0923\u0935\u0924\u094d\u0924\u093e \u0915\u0947 \u0938\u0916\u094d\u0924 \u092e\u093e\u0928\u0915\u094b\u0902 \u0915\u094b \u092a\u0942\u0930\u093e \u0915\u0930\u0947\u0902\u0964.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0935\u093f\u0937\u092f\u0938\u0942\u091a\u0940<\/h2><nav><ul><li><a href=\"#what-is-a-biologics-license-application-bla\">\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0915\u094d\u092f\u093e \u0939\u0948?<\/a><\/li><li><a href=\"#why-is-a-bla-important\">\u092c\u0940\u090f\u0932\u090f \u0915\u094d\u092f\u094b\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0939\u0948?<\/a><\/li><li><a href=\"#key-components-of-a-biologics-license-application\">\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0918\u091f\u0915<\/a><\/li><li><a href=\"#the-bla-review-and-approval-process\">\u092c\u0940\u090f\u0932\u090f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0914\u0930 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e<\/a><\/li><li><a href=\"#bla-vs-nda-whats-the-difference\">\u092c\u0940\u090f\u0932\u090f \u092c\u0928\u093e\u092e \u090f\u0928\u0921\u0940\u090f: \u0915\u094d\u092f\u093e \u0905\u0902\u0924\u0930 \u0939\u0948?<\/a><\/li><li><a href=\"#electronic-bla-e-bla-submissions\">\u0907\u0932\u0947\u0915\u094d\u091f\u094d\u0930\u0949\u0928\u093f\u0915 \u092c\u0940\u090f\u0932\u090f (\u0908\u092c\u0940\u090f\u0932\u090f) \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u092f\u093e\u0901<\/a><\/li><li><a href=\"#bla-supplements-and-amendments\">\u092c\u0940\u090f\u0932\u090f \u0905\u0928\u0941\u092a\u0942\u0930\u0915 \u0914\u0930 \u0938\u0902\u0936\u094b\u0927\u0928<\/a><\/li><li><a href=\"#tips-for-a-successful-bla-submission\">\u0938\u092b\u0932 \u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f \u0915\u0947 \u0932\u093f\u090f \u0938\u0941\u091d\u093e\u0935<\/a><\/li><li><a href=\"#fa-qs-about-bl-as\">\u092c\u0940\u090f\u0932\u090f \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u0905\u0915\u094d\u0938\u0930 \u092a\u0942\u091b\u0947 \u091c\u093e\u0928\u0947 \u0935\u093e\u0932\u0947 \u092a\u094d\u0930\u0936\u094d\u0928<\/a><ul><li><a href=\"#faq-question-1762183238646\">FDA \u092a\u0930 BLAs \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u094c\u0928 \u0915\u0930\u0924\u093e \u0939\u0948?<\/a><\/li><li><a href=\"#faq-question-1762183249315\">\u092c\u0940\u090f\u0932\u090f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092e\u0947\u0902 \u0915\u093f\u0924\u0928\u093e \u0938\u092e\u092f \u0932\u0917\u0924\u093e \u0939\u0948?<\/a><\/li><li><a href=\"#faq-question-1762183275484\">\u0915\u094d\u092f\u093e \u092c\u0940\u090f\u0932\u090f \u0915\u094b \u0935\u093e\u092a\u0938 \u0932\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0924\u093e \u0939\u0948?<\/a><\/li><li><a href=\"#faq-question-1762183285301\">\u092c\u0940\u090f\u0932\u090f \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092c\u093e\u0926 \u0915\u094d\u092f\u093e \u0939\u094b\u0924\u093e \u0939\u0948?<\/a><\/li><\/ul><\/li><li><a href=\"#conclusion\">\u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-a-biologics-license-application-bla\"><strong>\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0915\u094d\u092f\u093e \u0939\u0948?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0915\u093f\u0938\u0940 \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0947 \u0935\u093f\u092a\u0923\u0928 \u0939\u0947\u0924\u0941 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u0947 \u0939\u0947\u0924\u0941 \u0905\u092e\u0947\u0930\u093f\u0915\u0940 \u0916\u093e\u0926\u094d\u092f \u090f\u0935\u0902 \u0914\u0937\u0927\u093f \u092a\u094d\u0930\u0936\u093e\u0938\u0928 (1\u091f\u0940\u092a\u0940135\u091f\u0940) \u0915\u094b \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924 \u0915\u093f\u092f\u093e \u091c\u093e\u0928\u0947 \u0935\u093e\u0932\u093e \u090f\u0915 \u0914\u092a\u091a\u093e\u0930\u093f\u0915 \u0905\u0928\u0941\u0930\u094b\u0927 \u0939\u0948\u0964 \u092f\u0939 \u0906\u0935\u0947\u0926\u0928 \u0932\u094b\u0915 \u0938\u094d\u0935\u093e\u0938\u094d\u0925\u094d\u092f \u0938\u0947\u0935\u093e (\u092a\u0940\u090f\u091a\u090f\u0938) \u0905\u0927\u093f\u0928\u093f\u092f\u092e \u0915\u0947 \u0924\u0939\u0924 \u0906\u0935\u0936\u094d\u092f\u0915 \u0939\u0948 \u0914\u0930 \u091f\u0940\u0915\u094b\u0902, \u092e\u094b\u0928\u094b\u0915\u094d\u0932\u094b\u0928\u0932 \u090f\u0902\u091f\u0940\u092c\u0949\u0921\u0940, \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940, \u0938\u0947\u0932\u0941\u0932\u0930 \u0925\u0947\u0930\u0947\u092a\u0940 \u0914\u0930 \u092a\u0941\u0928\u0903 \u0938\u0902\u092f\u094b\u091c\u0915 \u092a\u094d\u0930\u094b\u091f\u0940\u0928 \u091c\u0948\u0938\u0947 \u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u092a\u0930 \u0932\u093e\u0917\u0942 \u0939\u094b\u0924\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0938\u0930\u0932 \u0936\u092c\u094d\u0926\u094b\u0902 \u092e\u0947\u0902, \u092c\u0940\u090f\u0932\u090f \u092f\u0939 \u0926\u0930\u094d\u0936\u093e\u0924\u093e \u0939\u0948 \u0915\u093f \u091c\u0948\u0935\u093f\u0915 \u0909\u0924\u094d\u092a\u093e\u0926 \u0905\u092a\u0928\u0947 \u0907\u091a\u094d\u091b\u093f\u0924 \u0909\u092a\u092f\u094b\u0917 \u0915\u0947 \u0932\u093f\u090f \u0938\u0941\u0930\u0915\u094d\u0937\u093f\u0924, \u0936\u0941\u0926\u094d\u0927 \u0914\u0930 \u0936\u0915\u094d\u0924\u093f\u0936\u093e\u0932\u0940 \u0939\u0948 \u0914\u0930 \u092f\u0939 \u0935\u0930\u094d\u0924\u092e\u093e\u0928 \u0905\u091a\u094d\u091b\u0947 \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u092a\u094d\u0930\u0925\u093e\u0913\u0902 (\u0938\u0940\u091c\u0940\u090f\u092e\u092a\u0940) \u0915\u0947 \u0905\u0928\u0941\u092a\u093e\u0932\u0928 \u092e\u0947\u0902 \u0928\u093f\u0930\u094d\u092e\u093f\u0924 \u0939\u0948\u0964.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"why-is-a-bla-important\"><strong>\u092c\u0940\u090f\u0932\u090f \u0915\u094d\u092f\u094b\u0902 \u092e\u0939\u0924\u094d\u0935\u092a\u0942\u0930\u094d\u0923 \u0939\u0948?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u092f\u0939 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u0930\u0928\u0947 \u0915\u0947 \u0932\u093f\u090f \u0906\u0935\u0936\u094d\u092f\u0915 \u0939\u0948 \u0915\u093f \u092c\u093e\u091c\u093c\u093e\u0930 \u092e\u0947\u0902 \u092a\u0939\u0941\u0901\u091a\u0928\u0947 \u0935\u093e\u0932\u0940 \u091c\u0948\u0935\u093f\u0915 \u0926\u0935\u093e\u090f\u0901 \u0915\u0920\u094b\u0930 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0914\u0930 \u0917\u0941\u0923\u0935\u0924\u094d\u0924\u093e \u092e\u093e\u0928\u0915\u094b\u0902 \u0915\u094b \u092a\u0942\u0930\u093e \u0915\u0930\u0947\u0902\u0964 \u091c\u0948\u0935\u093f\u0915 \u0926\u0935\u093e\u090f\u0901 \u0906\u092e\u0924\u094c\u0930 \u092a\u0930 \u092a\u093e\u0930\u0902\u092a\u0930\u093f\u0915 \u0932\u0918\u0941-\u0905\u0923\u0941 \u0926\u0935\u093e\u0913\u0902 \u0915\u0940 \u0924\u0941\u0932\u0928\u093e \u092e\u0947\u0902 \u0905\u0927\u093f\u0915 \u091c\u091f\u093f\u0932 \u0939\u094b\u0924\u0940 \u0939\u0948\u0902 \u0914\u0930 \u0905\u0915\u094d\u0938\u0930 \u0909\u0928\u0915\u0940 \u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u092e\u0947\u0902 \u091c\u0940\u0935\u093f\u0924 \u0915\u094b\u0936\u093f\u0915\u093e\u090f\u0901 \u092f\u093e \u091c\u0940\u0935 \u0936\u093e\u092e\u093f\u0932 \u0939\u094b\u0924\u0947 \u0939\u0948\u0902\u0964 \u0907\u0938 \u091c\u091f\u093f\u0932\u0924\u093e \u0915\u0947 \u0915\u093e\u0930\u0923, \u092c\u0940\u090f\u0932\u090f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0905\u0915\u094d\u0938\u0930 \u0928\u0908 \u0926\u0935\u093e \u0906\u0935\u0947\u0926\u0928 (\u090f\u0928\u0921\u0940\u090f) \u0915\u0940 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0938\u0947 \u0905\u0927\u093f\u0915 \u0935\u094d\u092f\u093e\u092a\u0915 \u0939\u094b\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u090f\u0915 \u0938\u092b\u0932 \u092c\u0940\u090f\u0932\u090f \u0915\u092e\u094d\u092a\u0928\u093f\u092f\u094b\u0902 \u0915\u094b \u092f\u0939 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0905\u0928\u0941\u092e\u0924\u093f \u0926\u0947\u0924\u093e \u0939\u0948:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u0905\u092a\u0928\u0947 \u091c\u0948\u0935\u093f\u0915 \u0909\u0924\u094d\u092a\u093e\u0926\u094b\u0902 \u0915\u093e \u0935\u094d\u092f\u093e\u0935\u0938\u093e\u092f\u0940\u0915\u0930\u0923 \u0914\u0930 \u0935\u093f\u0924\u0930\u0923 \u0915\u0930\u0928\u093e.<\/li>\n\n\n\n<li>\u090f\u0915 \u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0905\u0935\u0927\u093f \u0915\u0947 \u0932\u093f\u090f \u092c\u093e\u091c\u093e\u0930 \u092e\u0947\u0902 \u0935\u093f\u0936\u093f\u0937\u094d\u091f\u0924\u093e \u092a\u094d\u0930\u093e\u092a\u094d\u0924 \u0915\u0930\u0928\u093e\u0964.<\/li>\n\n\n\n<li>\u0928\u093f\u0935\u0947\u0936\u0915\u094b\u0902, \u0938\u094d\u0935\u093e\u0938\u094d\u0925\u094d\u092f \u0938\u0947\u0935\u093e \u092a\u094d\u0930\u0926\u093e\u0924\u093e\u0913\u0902 \u0914\u0930 \u0930\u094b\u0917\u093f\u092f\u094b\u0902 \u0915\u0947 \u0938\u093e\u0925 \u0935\u093f\u0936\u094d\u0935\u0938\u0928\u0940\u092f\u0924\u093e \u0938\u094d\u0925\u093e\u092a\u093f\u0924 \u0915\u0930\u0928\u093e\u0964.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"key-components-of-a-biologics-license-application\"><strong>\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0918\u091f\u0915<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u090f\u0915 \u092a\u0942\u0930\u094d\u0923 \u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f \u092e\u0947\u0902 \u092a\u094d\u0930\u0940\u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0914\u0930 \u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0935\u093f\u0915\u093e\u0938 \u0915\u0947 \u0926\u094c\u0930\u093e\u0928 \u0909\u0924\u094d\u092a\u0928\u094d\u0928 \u0935\u093f\u0936\u093e\u0932 \u092e\u093e\u0924\u094d\u0930\u093e \u092e\u0947\u0902 \u0921\u0947\u091f\u093e, \u0938\u093e\u0925 \u0939\u0940 \u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0914\u0930 \u0917\u0941\u0923\u0935\u0924\u094d\u0924\u093e \u0928\u093f\u092f\u0902\u0924\u094d\u0930\u0923 \u0938\u0902\u092c\u0902\u0927\u0940 \u0935\u093f\u0935\u0930\u0923 \u0936\u093e\u092e\u093f\u0932 \u0939\u094b\u0924\u0947 \u0939\u0948\u0902\u0964 \u092e\u0941\u0916\u094d\u092f \u0918\u091f\u0915 \u0939\u0948\u0902:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u092a\u094d\u0930\u0936\u093e\u0938\u0928\u093f\u0915 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0906\u0935\u0947\u0926\u0915 \u0915\u093e \u0928\u093e\u092e, \u092a\u0924\u093e \u0914\u0930 \u0938\u0902\u092a\u0930\u094d\u0915 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/li>\n\n\n\n<li>\u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u093e \u0928\u093e\u092e \u0914\u0930 \u0938\u094d\u0935\u093e\u092e\u093f\u0924\u094d\u0935 \u0938\u0902\u092c\u0902\u0927\u0940 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/li>\n\n\n\n<li>\u092a\u0947\u091f\u0947\u0902\u091f \u092a\u094d\u0930\u092e\u093e\u0923\u0928 \u0914\u0930 \u0932\u0947\u092c\u0932\u093f\u0902\u0917 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u092a\u094d\u0930\u0940\u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0921\u0947\u091f\u093e<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0917\u0948\u0930-\u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0914\u0930 \u0935\u093f\u0937\u093e\u0915\u094d\u0924\u0924\u093e \u0905\u0927\u094d\u092f\u092f\u0928<\/li>\n\n\n\n<li>\u092b\u093e\u0930\u094d\u092e\u093e\u0915\u094b\u0932\u0949\u091c\u0940 \u0921\u0947\u091f\u093e \u0914\u0930 \u0915\u094d\u0930\u093f\u092f\u093e \u0915\u093e \u0924\u0902\u0924\u094d\u0930<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0921\u0947\u091f\u093e<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u091a\u0930\u0923 1, 2 \u0914\u0930 3 \u0915\u0947 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u0947 \u092a\u0930\u093f\u0923\u093e\u092e<\/li>\n\n\n\n<li>\u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e \u0914\u0930 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0915\u094b \u092a\u094d\u0930\u0926\u0930\u094d\u0936\u093f\u0924 \u0915\u0930\u0928\u0947 \u0935\u093e\u0932\u0947 \u0938\u093e\u0902\u0916\u094d\u092f\u093f\u0915\u0940\u092f \u0935\u093f\u0936\u094d\u0932\u0947\u0937\u0923<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0930\u0938\u093e\u092f\u0928 \u0935\u093f\u091c\u094d\u091e\u093e\u0928, \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0914\u0930 \u0928\u093f\u092f\u0902\u0924\u094d\u0930\u0923 (\u0938\u0940\u090f\u092e\u0938\u0940)<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0914\u0930 \u0938\u0941\u0935\u093f\u0927\u093e \u0935\u093f\u0935\u0930\u0923<\/li>\n\n\n\n<li>\u0917\u0941\u0923\u0935\u0924\u094d\u0924\u093e \u0906\u0936\u094d\u0935\u093e\u0938\u0928 \u0914\u0930 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e\u090f\u0901<\/li>\n\n\n\n<li>\u092c\u0948\u091a \u0930\u093f\u0915\u0949\u0930\u094d\u0921, \u0935\u093f\u0928\u093f\u0930\u094d\u0926\u0947\u0936 \u0914\u0930 \u0938\u0924\u094d\u092f\u093e\u092a\u0928 \u0930\u093f\u092a\u094b\u0930\u094d\u091f<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0932\u0947\u092c\u0932\u093f\u0902\u0917 \u0914\u0930 \u092a\u0948\u0915\u0947\u091c\u093f\u0902\u0917<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u092a\u094d\u0930\u0938\u094d\u0924\u093e\u0935\u093f\u0924 \u092a\u094d\u0930\u093f\u0938\u094d\u0915\u094d\u0930\u093e\u0907\u092c\u093f\u0902\u0917 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/li>\n\n\n\n<li>\u092a\u0948\u0915\u0947\u091c\u093f\u0902\u0917 \u0921\u093f\u091c\u093c\u093e\u0907\u0928 \u0914\u0930 \u0930\u094b\u0917\u0940 \u0938\u0942\u091a\u0928\u093e \u092a\u0924\u094d\u0930\u0915<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u092a\u0930\u094d\u092f\u093e\u0935\u0930\u0923 \u0914\u0930 \u0938\u0941\u0935\u093f\u0927\u093e \u0938\u0902\u092c\u0902\u0927\u0940 \u091c\u093e\u0928\u0915\u093e\u0930\u0940<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u092a\u0930\u094d\u092f\u093e\u0935\u0930\u0923\u0940\u092f \u0906\u0915\u0932\u0928<\/li>\n\n\n\n<li>\u0928\u093f\u0930\u0940\u0915\u094d\u0937\u0923 \u0924\u0924\u094d\u092a\u0930\u0924\u093e \u0926\u0938\u094d\u0924\u093e\u0935\u0947\u091c\u093c\u0940\u0915\u0930\u0923<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"the-bla-review-and-approval-process\"><strong>\u092c\u0940\u090f\u0932\u090f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0914\u0930 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA \u0915\u093e \u091c\u0948\u0935\u093f\u0915 \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u090f\u0935\u0902 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928 \u0915\u0947\u0902\u0926\u094d\u0930 (CBER) \u092f\u093e \u0914\u0937\u0927\u093f \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u090f\u0935\u0902 \u0905\u0928\u0941\u0938\u0902\u0927\u093e\u0928 \u0915\u0947\u0902\u0926\u094d\u0930 (CDER) \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0947 \u092a\u094d\u0930\u0915\u093e\u0930 \u0915\u0947 \u0906\u0927\u093e\u0930 \u092a\u0930 BLA \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u0930\u0924\u093e \u0939\u0948\u0964 \u092f\u0939 \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0906\u092e \u0924\u094c\u0930 \u092a\u0930 \u0907\u0928 \u091a\u0930\u0923\u094b\u0902 \u0915\u093e \u092a\u093e\u0932\u0928 \u0915\u0930\u0924\u0940 \u0939\u0948:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u092a\u094d\u0930\u0940-\u092c\u0940\u090f\u0932\u090f \u092c\u0948\u0920\u0915<\/strong><br>\u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915 FDA \u0915\u0947 \u0938\u093e\u0925 \u092c\u0948\u0920\u0915 \u0915\u0930 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u0915\u0930\u0923 \u0915\u0940 \u0924\u0924\u094d\u092a\u0930\u0924\u093e \u092a\u0930 \u091a\u0930\u094d\u091a\u093e \u0915\u0930\u0924\u0947 \u0939\u0948\u0902 \u0924\u0925\u093e \u0928\u093f\u092f\u093e\u092e\u0915 \u0905\u092a\u0947\u0915\u094d\u0937\u093e\u0913\u0902 \u0915\u094b \u0938\u094d\u092a\u0937\u094d\u091f \u0915\u0930\u0924\u0947 \u0939\u0948\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u092c\u0940\u090f\u0932\u090f \u0938\u092c\u092e\u093f\u0936\u0928 \u0914\u0930 \u092b\u093e\u0907\u0932\u093f\u0902\u0917 \u0938\u092e\u0940\u0915\u094d\u0937\u093e<\/strong><br>FDA 60-\u0926\u093f\u0935\u0938\u0940\u092f \u092b\u093e\u0907\u0932\u093f\u0902\u0917 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0906\u092f\u094b\u091c\u093f\u0924 \u0915\u0930\u0924\u093e \u0939\u0948, \u0924\u093e\u0915\u093f \u092f\u0939 \u0928\u093f\u0930\u094d\u0927\u093e\u0930\u093f\u0924 \u0915\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0947 \u0915\u093f \u0906\u0935\u0947\u0926\u0928 \u0935\u093f\u0938\u094d\u0924\u0943\u0924 \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u0915\u0947 \u0932\u093f\u090f \u092a\u0930\u094d\u092f\u093e\u092a\u094d\u0924 \u0930\u0942\u092a \u0938\u0947 \u092a\u0942\u0930\u094d\u0923 \u0939\u0948 \u092f\u093e \u0928\u0939\u0940\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u0935\u094d\u092f\u093e\u092a\u0915 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u091a\u0930\u0923<\/strong><br>\u090f\u091c\u0947\u0902\u0938\u0940 \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u0921\u0947\u091f\u093e, \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u091c\u093e\u0928\u0915\u093e\u0930\u0940 \u0914\u0930 \u0932\u0947\u092c\u0932\u093f\u0902\u0917 \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u0930\u0924\u0940 \u0939\u0948\u0964 \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0938\u094d\u0925\u0932\u094b\u0902 \u0915\u093e \u0928\u093f\u0930\u0940\u0915\u094d\u0937\u0923 \u092d\u0940 \u0915\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0924\u093e \u0939\u0948\u0964.<\/li>\n\n\n\n<li><strong>\u0938\u0932\u093e\u0939\u0915\u093e\u0930 \u0938\u092e\u093f\u0924\u093f \u0915\u0940 \u092c\u0948\u0920\u0915 (\u092f\u0926\u093f \u0932\u093e\u0917\u0942 \u0939\u094b)<\/strong><br>\u0938\u094d\u0935\u0924\u0902\u0924\u094d\u0930 \u0935\u093f\u0936\u0947\u0937\u091c\u094d\u091e \u0906\u0935\u0947\u0926\u0928 \u0915\u093e \u092e\u0942\u0932\u094d\u092f\u093e\u0902\u0915\u0928 \u0915\u0930 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902 \u0914\u0930 \u0938\u093f\u092b\u093e\u0930\u093f\u0936\u0947\u0902 \u0926\u0947 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902\u0964.<\/li>\n\n\n\n<li><strong>FDA \u0928\u093f\u0930\u094d\u0923\u092f<\/strong><br>FDA \u092f\u093e \u0924\u094b \u090f\u0915 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092a\u0924\u094d\u0930 \u092f\u093e \u090f\u0915 \u092a\u0942\u0930\u094d\u0923 \u092a\u094d\u0930\u0924\u093f\u0915\u094d\u0930\u093f\u092f\u093e \u092a\u0924\u094d\u0930 (CRL) \u091c\u093e\u0930\u0940 \u0915\u0930\u0924\u093e \u0939\u0948 \u091c\u093f\u0938\u092e\u0947\u0902 \u0909\u0928 \u0915\u092e\u093f\u092f\u094b\u0902 \u0915\u094b \u0930\u0947\u0916\u093e\u0902\u0915\u093f\u0924 \u0915\u093f\u092f\u093e \u091c\u093e\u0924\u093e \u0939\u0948 \u091c\u093f\u0928\u094d\u0939\u0947\u0902 \u0938\u0902\u092c\u094b\u0927\u093f\u0924 \u0915\u093f\u092f\u093e \u091c\u093e\u0928\u093e \u091a\u093e\u0939\u093f\u090f\u0964.<\/li>\n\n\n\n<li><strong>\u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092c\u093e\u0926 \u0915\u0940 \u092a\u094d\u0930\u0924\u093f\u092c\u0926\u094d\u0927\u0924\u093e\u090f\u0901<\/strong><br>\u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915\u094b\u0902 \u0915\u094b \u0935\u093f\u092a\u0923\u0928-\u092a\u0936\u094d\u091a\u093e\u0924 \u0905\u0927\u094d\u092f\u092f\u0928 \u092f\u093e \u091a\u0930\u0923 4 \u092a\u094d\u0930\u0924\u093f\u092c\u0926\u094d\u0927\u0924\u093e\u090f\u0902 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e \u0939\u094b \u0938\u0915\u0924\u0940 \u0939\u0948\u0964.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"bla-vs-nda-whats-the-difference\"><strong>\u092c\u0940\u090f\u0932\u090f \u092c\u0928\u093e\u092e \u090f\u0928\u0921\u0940\u090f: \u0915\u094d\u092f\u093e \u0905\u0902\u0924\u0930 \u0939\u0948?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092f\u0926\u094d\u092f\u092a\u093f \u092c\u0940\u090f\u0932\u090f \u0914\u0930 \u090f\u0928\u0921\u0940\u090f \u0926\u094b\u0928\u094b\u0902 \u0939\u0940 1\u091f\u0940\u092a\u0940135\u091f\u0940 \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092e\u093e\u0930\u094d\u0917 \u0939\u0948\u0902, \u092b\u093f\u0930 \u092d\u0940 \u0935\u0947 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0947 \u092a\u094d\u0930\u0915\u093e\u0930 \u0915\u0947 \u0906\u0927\u093e\u0930 \u092a\u0930 \u092d\u093f\u0928\u094d\u0928 \u0939\u094b\u0924\u0947 \u0939\u0948\u0902:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u092a\u0939\u0932\u0942<\/strong><\/th><th><strong>\u092c\u0940\u090f\u0932\u090f (\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938)<\/strong><\/th><th><strong>\u090f\u0928\u0921\u0940\u090f (\u0921\u094d\u0930\u0917\u094d\u0938)<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u0928\u093f\u092f\u093e\u092e\u0915 \u092a\u094d\u0930\u093e\u0927\u093f\u0915\u0930\u0923<\/td><td>\u092a\u0940\u090f\u091a\u090f\u0938 \u0905\u0927\u093f\u0928\u093f\u092f\u092e<\/td><td>\u0938\u0902\u0918\u0940\u092f \u0916\u093e\u0926\u094d\u092f, \u0914\u0937\u0927\u093f \u0914\u0930 \u092a\u094d\u0930\u0938\u093e\u0927\u0928 \u0938\u093e\u092e\u0917\u094d\u0930\u0940 \u0905\u0927\u093f\u0928\u093f\u092f\u092e<\/td><\/tr><tr><td>\u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u093e \u092a\u094d\u0930\u0915\u093e\u0930<\/td><td>\u091c\u0948\u0935\u093f\u0915 \u092a\u0926\u093e\u0930\u094d\u0925 (\u092a\u094d\u0930\u094b\u091f\u0940\u0928, \u0915\u094b\u0936\u093f\u0915\u093e\u090f\u0902, \u091f\u0940\u0915\u0947)<\/td><td>\u091b\u094b\u091f\u0947-\u0905\u0923\u0941 \u0935\u093e\u0932\u0940 \u0926\u0935\u093e\u090f\u0902<\/td><\/tr><tr><td>\u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u092d\u093e\u0917<\/td><td>\u0938\u0940\u092c\u0940\u0908\u0906\u0930 \u092f\u093e \u0938\u0940\u0921\u0940\u0908\u0906\u0930<\/td><td>\u0938\u0940\u0921\u0940\u0908\u0906\u0930<\/td><\/tr><tr><td>\u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u092b\u094b\u0915\u0938<\/td><td>\u0938\u0941\u0930\u0915\u094d\u0937\u093e, \u0936\u0941\u0926\u094d\u0927\u0924\u093e \u0914\u0930 \u0915\u094d\u0937\u092e\u0924\u093e<\/td><td>\u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0914\u0930 \u092a\u094d\u0930\u092d\u093e\u0935\u0915\u093e\u0930\u093f\u0924\u093e<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"electronic-bla-e-bla-submissions\"><strong>\u0907\u0932\u0947\u0915\u094d\u091f\u094d\u0930\u0949\u0928\u093f\u0915 \u092c\u0940\u090f\u0932\u090f (\u0908\u092c\u0940\u090f\u0932\u090f) \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u092f\u093e\u0901<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">FDA, eCTD (\u0907\u0932\u0947\u0915\u094d\u091f\u094d\u0930\u0949\u0928\u093f\u0915 \u0915\u0949\u092e\u0928 \u091f\u0947\u0915\u094d\u0928\u093f\u0915\u0932 \u0921\u0949\u0915\u094d\u092f\u0942\u092e\u0947\u0902\u091f) \u092a\u094d\u0930\u093e\u0930\u0942\u092a \u092e\u0947\u0902 \u0907\u0932\u0947\u0915\u094d\u091f\u094d\u0930\u0949\u0928\u093f\u0915 \u0938\u092c\u092e\u093f\u0936\u0928 \u0915\u0947 \u0909\u092a\u092f\u094b\u0917 \u0915\u094b \u092a\u094d\u0930\u094b\u0924\u094d\u0938\u093e\u0939\u093f\u0924 \u0915\u0930\u0924\u093e \u0939\u0948\u0964 \u092f\u0939 \u092e\u093e\u0928\u0915 \u0938\u092d\u0940 BLA \u0918\u091f\u0915\u094b\u0902 \u092e\u0947\u0902 \u090f\u0915\u0930\u0942\u092a\u0924\u093e, \u0905\u0928\u0941\u0930\u0947\u0916\u0923\u0940\u092f\u0924\u093e \u0914\u0930 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092e\u0947\u0902 \u0906\u0938\u093e\u0928\u0940 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u0930\u0924\u093e \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0908\u092c\u0940\u090f\u0932\u090f \u0915\u0947 \u092a\u094d\u0930\u092e\u0941\u0916 \u0932\u093e\u092d\u094b\u0902 \u092e\u0947\u0902 \u0936\u093e\u092e\u093f\u0932 \u0939\u0948\u0902:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA \u0915\u0947 \u0938\u093e\u0925 \u0938\u0941\u0935\u094d\u092f\u0935\u0938\u094d\u0925\u093f\u0924 \u0938\u0902\u091a\u093e\u0930<\/li>\n\n\n\n<li>\u092a\u094d\u0930\u0936\u093e\u0938\u0928\u093f\u0915 \u092c\u094b\u091d \u092e\u0947\u0902 \u0915\u092e\u0940<\/li>\n\n\n\n<li>\u0924\u0947\u091c\u093c \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0938\u092e\u092f\u0938\u0940\u092e\u093e<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"bla-supplements-and-amendments\"><strong>\u092c\u0940\u090f\u0932\u090f \u0905\u0928\u0941\u092a\u0942\u0930\u0915 \u0914\u0930 \u0938\u0902\u0936\u094b\u0927\u0928<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u090f\u0915 \u092c\u093e\u0930 \u092c\u0940\u090f\u0932\u090f \u0915\u094b \u092e\u0902\u091c\u0942\u0930\u0940 \u092e\u093f\u0932 \u091c\u093e\u0928\u0947 \u0915\u0947 \u092c\u093e\u0926, \u0928\u093f\u0930\u094d\u092e\u093e\u0924\u093e\u0913\u0902 \u0915\u094b \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092c\u093e\u0926 \u0915\u0941\u091b \u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928 \u0915\u0930\u0928\u0947 \u0915\u0940 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e \u0939\u094b \u0938\u0915\u0924\u0940 \u0939\u0948, \u091c\u0948\u0938\u0947:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0928\u090f \u0938\u0902\u0915\u0947\u0924 \u092f\u093e \u0916\u0941\u0930\u093e\u0915 \u0915\u0947 \u0930\u0942\u092a<\/li>\n\n\n\n<li>\u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0938\u094d\u0925\u0932 \u092e\u0947\u0902 \u092a\u0930\u093f\u0935\u0930\u094d\u0924\u0928<\/li>\n\n\n\n<li>\u0932\u0947\u092c\u0932\u093f\u0902\u0917 \u0905\u092a\u0921\u0947\u091f<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0907\u0928 \u0938\u0902\u0936\u094b\u0927\u0928\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u092c\u0940\u090f\u0932\u090f \u0905\u0928\u0941\u092a\u0942\u0930\u0915\u094b\u0902 \u0915\u0940 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e \u0939\u094b\u0924\u0940 \u0939\u0948, \u091c\u093f\u0928\u0915\u0940 \u0909\u0924\u094d\u092a\u093e\u0926 \u0915\u0940 \u0917\u0941\u0923\u0935\u0924\u094d\u0924\u093e \u092f\u093e \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u092a\u0930 \u0909\u0928\u0915\u0947 \u092a\u094d\u0930\u092d\u093e\u0935 \u0915\u0947 \u0906\u0927\u093e\u0930 \u092a\u0930 \u0905\u0932\u0917 \u0938\u0947 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u0940 \u091c\u093e\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"tips-for-a-successful-bla-submission\"><strong>\u0938\u092b\u0932 \u092c\u0940\u090f\u0932\u090f \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f \u0915\u0947 \u0932\u093f\u090f \u0938\u0941\u091d\u093e\u0935<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FDA \u0915\u0947 \u0938\u093e\u0925 \u0936\u0940\u0918\u094d\u0930 \u091c\u0941\u0921\u093c\u0947\u0902:<\/strong> \u092a\u0942\u0930\u094d\u0935-\u092c\u0940\u090f\u0932\u090f \u092c\u0948\u0920\u0915\u094b\u0902 \u0915\u093e \u0915\u093e\u0930\u094d\u092f\u0915\u094d\u0930\u092e \u092c\u0928\u093e\u090f\u0902 \u0914\u0930 \u0905\u092a\u0947\u0915\u094d\u0937\u093e\u0913\u0902 \u0915\u094b \u0938\u094d\u092a\u0937\u094d\u091f \u0915\u0930\u0947\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u0938\u0902\u092a\u0942\u0930\u094d\u0923 \u0926\u0938\u094d\u0924\u093e\u0935\u0947\u091c \u092c\u0928\u093e\u090f \u0930\u0916\u0947\u0902:<\/strong> \u092a\u094d\u0930\u0940\u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932, \u0915\u094d\u0932\u093f\u0928\u093f\u0915\u0932 \u0914\u0930 \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0905\u0928\u0941\u092d\u093e\u0917\u094b\u0902 \u092e\u0947\u0902 \u0921\u0947\u091f\u093e \u0905\u0916\u0902\u0921\u0924\u093e \u0914\u0930 \u091f\u094d\u0930\u0947\u0938\u093f\u092c\u093f\u0932\u093f\u091f\u0940 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u0930\u0947\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u0938\u0940\u090f\u092e\u0938\u0940 \u0915\u0940 \u0924\u0948\u092f\u093e\u0930\u0940 \u092a\u0930 \u0927\u094d\u092f\u093e\u0928 \u0915\u0947\u0902\u0926\u094d\u0930\u093f\u0924:<\/strong> \u0935\u093f\u0928\u093f\u0930\u094d\u092e\u093e\u0923 \u0938\u0902\u092c\u0902\u0927\u0940 \u092e\u0941\u0926\u094d\u0926\u0947 \u092c\u0940\u090f\u0932\u090f \u0935\u093f\u0932\u0902\u092c \u0915\u0947 \u0938\u092c\u0938\u0947 \u0938\u093e\u092e\u093e\u0928\u094d\u092f \u0915\u093e\u0930\u0923\u094b\u0902 \u092e\u0947\u0902 \u0938\u0947 \u0939\u0948\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u0928\u093f\u0930\u0940\u0915\u094d\u0937\u0923 \u0915\u0940 \u092f\u094b\u091c\u0928\u093e:<\/strong> \u0911\u0921\u093f\u091f \u0915\u0947 \u0932\u093f\u090f \u0924\u0948\u092f\u093e\u0930 \u0930\u0939\u0947\u0902 \u0914\u0930 \u0935\u093f\u0938\u094d\u0924\u0943\u0924 \u0938\u0941\u0935\u093f\u0927\u093e \u0914\u0930 \u092c\u0948\u091a \u0930\u093f\u0915\u0949\u0930\u094d\u0921 \u092c\u0928\u093e\u090f \u0930\u0916\u0947\u0902\u0964.<\/li>\n\n\n\n<li><strong>\u0932\u0940\u0935\u0930\u0947\u091c \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u0932\u093e\u0939\u0915\u093e\u0930:<\/strong> \u0905\u0928\u0941\u092d\u0935\u0940 \u0935\u093f\u0936\u0947\u0937\u091c\u094d\u091e FDA \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e\u0913\u0902 \u0914\u0930 \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u0915\u0930\u0923 \u0915\u0940 \u092c\u093e\u0930\u0940\u0915\u093f\u092f\u094b\u0902 \u0915\u094b \u0938\u092e\u091d\u0928\u0947 \u092e\u0947\u0902 \u092e\u0926\u0926 \u0915\u0930 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902\u0964.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"fa-qs-about-bl-as\"><strong>\u092c\u0940\u090f\u0932\u090f \u0915\u0947 \u092c\u093e\u0930\u0947 \u092e\u0947\u0902 \u0905\u0915\u094d\u0938\u0930 \u092a\u0942\u091b\u0947 \u091c\u093e\u0928\u0947 \u0935\u093e\u0932\u0947 \u092a\u094d\u0930\u0936\u094d\u0928<\/strong><\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1762183238646\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">FDA \u092a\u0930 BLAs \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0915\u094c\u0928 \u0915\u0930\u0924\u093e \u0939\u0948?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u092c\u0940\u090f\u0932\u090f \u0915\u0940 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0938\u0940\u092c\u0940\u0908\u0906\u0930 \u092f\u093e \u0938\u0940\u0921\u0940\u0908\u0906\u0930 \u0926\u094d\u0935\u093e\u0930\u093e \u0915\u0940 \u091c\u093e\u0924\u0940 \u0939\u0948, \u091c\u094b \u091c\u0948\u0935\u093f\u0915 \u0915\u0947 \u092a\u094d\u0930\u0915\u093e\u0930 \u0914\u0930 \u0938\u0902\u0915\u0947\u0924 \u092a\u0930 \u0928\u093f\u0930\u094d\u092d\u0930 \u0915\u0930\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183249315\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u092c\u0940\u090f\u0932\u090f \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092e\u0947\u0902 \u0915\u093f\u0924\u0928\u093e \u0938\u092e\u092f \u0932\u0917\u0924\u093e \u0939\u0948?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u092e\u093e\u0928\u0915 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0938\u092e\u092f-\u0938\u0940\u092e\u093e 10 \u092e\u0939\u0940\u0928\u0947 \u0939\u0948, \u091c\u092c\u0915\u093f \u092a\u094d\u0930\u093e\u0925\u092e\u093f\u0915\u0924\u093e \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0907\u0938\u0947 \u0918\u091f\u093e\u0915\u0930 6 \u092e\u0939\u0940\u0928\u0947 \u0915\u0930 \u0938\u0915\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183275484\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u0915\u094d\u092f\u093e \u092c\u0940\u090f\u0932\u090f \u0915\u094b \u0935\u093e\u092a\u0938 \u0932\u093f\u092f\u093e \u091c\u093e \u0938\u0915\u0924\u093e \u0939\u0948?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u0939\u093e\u0902, \u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915 FDA \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u0938\u0947 \u092a\u0939\u0932\u0947 \u092f\u093e \u092c\u093e\u0926 \u092e\u0947\u0902 \u0915\u093f\u0938\u0940 \u092d\u0940 \u0938\u092e\u092f \u0938\u094d\u0935\u0947\u091a\u094d\u091b\u093e \u0938\u0947 BLA \u0935\u093e\u092a\u0938 \u0932\u0947 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902\u0964.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183285301\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u092c\u0940\u090f\u0932\u090f \u0905\u0928\u0941\u092e\u094b\u0926\u0928 \u0915\u0947 \u092c\u093e\u0926 \u0915\u094d\u092f\u093e \u0939\u094b\u0924\u093e \u0939\u0948?<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u0928\u093f\u0930\u094d\u092e\u093e\u0924\u093e\u0913\u0902 \u0915\u094b \u0935\u093f\u092a\u0923\u0928-\u092a\u0936\u094d\u091a\u093e\u0924 \u0928\u093f\u0917\u0930\u093e\u0928\u0940, \u0906\u0935\u0927\u093f\u0915 \u0938\u0941\u0930\u0915\u094d\u0937\u093e \u0930\u093f\u092a\u094b\u0930\u094d\u091f\u093f\u0902\u0917, \u0924\u0925\u093e \u0915\u093f\u0938\u0940 \u092d\u0940 \u0905\u0924\u093f\u0930\u093f\u0915\u094d\u0924 FDA-\u0932\u0917\u093e\u090f \u0917\u090f \u0905\u0927\u094d\u092f\u092f\u0928 \u0915\u093e \u0905\u0928\u0941\u092a\u093e\u0932\u0928 \u0915\u0930\u0928\u093e \u0939\u094b\u0917\u093e\u0964.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"conclusion\"><strong>\u0928\u093f\u0937\u094d\u0915\u0930\u094d\u0937<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u092c\u093e\u092f\u094b\u0932\u0949\u091c\u093f\u0915\u094d\u0938 \u0932\u093e\u0907\u0938\u0947\u0902\u0938 \u0906\u0935\u0947\u0926\u0928 (\u092c\u0940\u090f\u0932\u090f) \u0938\u0902\u092f\u0941\u0915\u094d\u0924 \u0930\u093e\u091c\u094d\u092f \u0905\u092e\u0947\u0930\u093f\u0915\u093e \u092e\u0947\u0902 \u091c\u0948\u0935\u093f\u0915 \u0909\u0924\u094d\u092a\u093e\u0926\u094b\u0902 \u0915\u0947 \u0932\u093f\u090f \u0928\u093f\u092f\u093e\u092e\u0915 \u092e\u093e\u0930\u094d\u0917 \u0915\u093e \u0906\u0927\u093e\u0930 \u0939\u0948\u0964 \u092c\u0940\u090f\u0932\u090f \u0938\u0902\u0930\u091a\u0928\u093e, \u092a\u094d\u0930\u0938\u094d\u0924\u0941\u0924\u093f\u0915\u0930\u0923 \u0906\u0935\u0936\u094d\u092f\u0915\u0924\u093e\u0913\u0902 \u0914\u0930 \u0938\u092e\u0940\u0915\u094d\u0937\u093e \u092a\u094d\u0930\u0915\u094d\u0930\u093f\u092f\u093e \u0915\u094b \u0938\u092e\u091d\u0915\u0930, \u092a\u094d\u0930\u093e\u092f\u094b\u091c\u0915 FDA \u092e\u093e\u0928\u0915\u094b\u0902 \u0915\u093e \u0905\u0928\u0941\u092a\u093e\u0932\u0928 \u0938\u0941\u0928\u093f\u0936\u094d\u091a\u093f\u0924 \u0915\u0930\u0924\u0947 \u0939\u0941\u090f \u092c\u093e\u091c\u093c\u093e\u0930 \u0924\u0915 \u0905\u092a\u0928\u0940 \u092a\u0939\u0941\u0901\u091a \u0915\u094b \u0938\u0941\u0935\u094d\u092f\u0935\u0938\u094d\u0925\u093f\u0924 \u0915\u0930 \u0938\u0915\u0924\u0947 \u0939\u0948\u0902\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u091a\u093e\u0939\u0947 \u0935\u0948\u0915\u094d\u0938\u0940\u0928, \u091c\u0940\u0928 \u0925\u0947\u0930\u0947\u092a\u0940 \u092f\u093e \u092e\u094b\u0928\u094b\u0915\u094d\u0932\u094b\u0928\u0932 \u090f\u0902\u091f\u0940\u092c\u0949\u0921\u0940 \u0915\u093e \u0935\u093f\u0915\u093e\u0938 \u0939\u094b, \u092c\u0940\u090f\u0932\u090f \u0915\u0940 \u0938\u093e\u0935\u0927\u093e\u0928\u0940\u092a\u0942\u0930\u094d\u0935\u0915 \u0924\u0948\u092f\u093e\u0930\u0940 \u0928\u093f\u092f\u093e\u092e\u0915 \u0938\u092b\u0932\u0924\u093e \u0914\u0930 \u092e\u0939\u0902\u0917\u0940 \u0926\u0947\u0930\u0940 \u0915\u0947 \u092c\u0940\u091a \u0905\u0902\u0924\u0930 \u0932\u093e \u0938\u0915\u0924\u0940 \u0939\u0948\u0964.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0914\u0930 \u092a\u0922\u093c\u0947\u0902<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/hi\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0921\u094d\u092f\u0942\u0936\u0947\u0928 \u0915\u0947 \u0932\u093f\u090f \u0928\u0948\u0926\u093e\u0928\u093f\u0915 \u092a\u0930\u0940\u0915\u094d\u0937\u0923 (\u0938\u092d\u0940 \u0936\u094b\u0927\u094b\u0902 \u0915\u0940 \u0938\u0942\u091a\u0940)<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><br><\/p>","protected":false},"excerpt":{"rendered":"<p>The Biologics License Application (BLA) plays a critical role in bringing new biologic therapies for Duchenne Muscular Dystrophy (DMD) to patients. A BLA is the formal submission that a biotechnology or pharmaceutical company makes to the U.S. Food and Drug Administration (FDA) to request approval for marketing a biologic product. In the context of Duchenne, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5030,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[128,88],"class_list":["post-5027","post","type-post","status-publish","format-standard","has-post-thumbnail","category-dmd","tag-bla","tag-fda"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/5027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/comments?post=5027"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/posts\/5027\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media\/5030"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/media?parent=5027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/categories?post=5027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/hi\/wp-json\/wp\/v2\/tags?post=5027"}],"curies":[{"name":"\u0921\u092c\u094d\u0932\u094d\u092f\u0942\u092a\u0940","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}