{"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\/ar\/biologics-license-application-bla\/","title":{"rendered":"\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA): \u062f\u0644\u064a\u0644 \u0643\u0627\u0645\u0644 \u0644\u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 FDA"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>\u064a\u0644\u0639\u0628 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA) \u062f\u0648\u0631\u064b\u0627 \u062d\u0627\u0633\u0645\u064b\u0627 \u0641\u064a \u062a\u0648\u0641\u064a\u0631 \u0639\u0644\u0627\u062c\u0627\u062a \u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u062c\u062f\u064a\u062f\u0629 \u0644\u0645\u0631\u0636 \u0636\u0645\u0648\u0631 \u0627\u0644\u0639\u0636\u0644\u0627\u062a \u062f\u0648\u0634\u064a\u0646 (DMD) \u0644\u0644\u0645\u0631\u0636\u0649.<\/strong> \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a (BLA) \u0647\u0648 \u0627\u0644\u0637\u0644\u0628 \u0627\u0644\u0631\u0633\u0645\u064a \u0627\u0644\u0630\u064a \u062a\u0642\u062f\u0645\u0647 \u0634\u0631\u0643\u0629 \u062a\u0643\u0646\u0648\u0644\u0648\u062c\u064a\u0627 \u062d\u064a\u0648\u064a\u0629 \u0623\u0648 \u0634\u0631\u0643\u0629 \u0623\u062f\u0648\u064a\u0629 \u0625\u0644\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA) \u0644\u0637\u0644\u0628 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 \u062a\u0633\u0648\u064a\u0642 \u0645\u0646\u062a\u062c \u0628\u064a\u0648\u0644\u0648\u062c\u064a. \u0641\u064a \u0633\u064a\u0627\u0642 \u0645\u0631\u0636 \u062f\u0648\u0634\u064a\u0646\u060c \u062d\u064a\u062b \u062a\u062a\u0637\u0648\u0631 \u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u0645\u062a\u0637\u0648\u0631\u0629\u060c \u0645\u062b\u0644 \u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u062c\u064a\u0646\u064a\u0629\u060c \u0648\u0623\u062f\u0648\u064a\u0629 \u062a\u062e\u0637\u064a \u0627\u0644\u0625\u0643\u0633\u0648\u0646\u0627\u062a\u060c \u0648\u0627\u0644\u0623\u062c\u0633\u0627\u0645 \u0627\u0644\u0645\u0636\u0627\u062f\u0629 \u0648\u062d\u064a\u062f\u0629 \u0627\u0644\u0646\u0633\u064a\u0644\u0629\u060c \u0628\u0648\u062a\u064a\u0631\u0629 \u0645\u062a\u0633\u0627\u0631\u0639\u0629\u060c \u064a\u064f\u0639\u062f \u0641\u0647\u0645 \u0639\u0645\u0644\u064a\u0629 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0623\u0645\u0631\u064b\u0627 \u0628\u0627\u0644\u063a \u0627\u0644\u0623\u0647\u0645\u064a\u0629. \u0641\u0647\u0648 \u064a\u0636\u0645\u0646 \u0627\u0633\u062a\u064a\u0641\u0627\u0621 \u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u0648\u0627\u0639\u062f\u0629 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0635\u0627\u0631\u0645\u0629 \u0644\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629 \u0648\u0627\u0644\u062c\u0648\u062f\u0629 \u0642\u0628\u0644 \u0648\u0635\u0648\u0644\u0647\u0627 \u0625\u0644\u0649 \u0627\u0644\u0645\u0631\u0636\u0649.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u062c\u062f\u0648\u0644 \u0627\u0644\u0645\u062d\u062a\u0648\u064a\u0627\u062a<\/h2><nav><ul><li><a href=\"#what-is-a-biologics-license-application-bla\">\u0645\u0627 \u0647\u0648 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA)\u061f<\/a><\/li><li><a href=\"#why-is-a-bla-important\">\u0644\u0645\u0627\u0630\u0627 \u064a\u0639\u062a\u0628\u0631 BLA \u0645\u0647\u0645\u064b\u0627\u061f<\/a><\/li><li><a href=\"#key-components-of-a-biologics-license-application\">\u0627\u0644\u0645\u0643\u0648\u0646\u0627\u062a \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0644\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629<\/a><\/li><li><a href=\"#the-bla-review-and-approval-process\">\u0639\u0645\u0644\u064a\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 \u0648\u0627\u0639\u062a\u0645\u0627\u062f BLA<\/a><\/li><li><a href=\"#bla-vs-nda-whats-the-difference\">BLA \u0645\u0642\u0627\u0628\u0644 NDA: \u0645\u0627 \u0647\u0648 \u0627\u0644\u0641\u0631\u0642\u061f<\/a><\/li><li><a href=\"#electronic-bla-e-bla-submissions\">\u0625\u0631\u0633\u0627\u0644\u064a\u0627\u062a BLA \u0627\u0644\u0625\u0644\u0643\u062a\u0631\u0648\u0646\u064a\u0629 (eBLA)<\/a><\/li><li><a href=\"#bla-supplements-and-amendments\">\u0645\u0644\u0627\u062d\u0642 \u0648\u062a\u0639\u062f\u064a\u0644\u0627\u062a \u0642\u0627\u0646\u0648\u0646 BLA<\/a><\/li><li><a href=\"#tips-for-a-successful-bla-submission\">\u0646\u0635\u0627\u0626\u062d \u0644\u062a\u0642\u062f\u064a\u0645 \u0637\u0644\u0628 BLA \u0646\u0627\u062c\u062d<\/a><\/li><li><a href=\"#fa-qs-about-bl-as\">\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u062d\u0648\u0644 BLAs<\/a><ul><li><a href=\"#faq-question-1762183238646\">\u0645\u0646 \u064a\u0631\u0627\u062c\u0639 BLAs \u0641\u064a FDA\u061f<\/a><\/li><li><a href=\"#faq-question-1762183249315\">\u0643\u0645 \u0645\u0646 \u0627\u0644\u0648\u0642\u062a \u062a\u0633\u062a\u063a\u0631\u0642 \u0639\u0645\u0644\u064a\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 BLA\u061f<\/a><\/li><li><a href=\"#faq-question-1762183275484\">\u0647\u0644 \u064a\u0645\u0643\u0646 \u0633\u062d\u0628 BLA\u061f<\/a><\/li><li><a href=\"#faq-question-1762183285301\">\u0645\u0627\u0630\u0627 \u064a\u062d\u062f\u062b \u0628\u0639\u062f \u0645\u0648\u0627\u0641\u0642\u0629 BLA\u061f<\/a><\/li><\/ul><\/li><li><a href=\"#conclusion\">\u062e\u0627\u062a\u0645\u0629<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-a-biologics-license-application-bla\"><strong>\u0645\u0627 \u0647\u0648 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA)\u061f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA) \u0647\u0648 \u0637\u0644\u0628 \u0631\u0633\u0645\u064a \u064a\u064f\u0642\u062f\u0651\u0645 \u0625\u0644\u0649 \u0625\u062f\u0627\u0631\u0629 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0627\u0644\u0623\u0645\u0631\u064a\u0643\u064a\u0629 (FDA) \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0645\u0648\u0627\u0641\u0642\u0629 \u062a\u0633\u0648\u064a\u0642 \u0645\u0646\u062a\u062c \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629. \u0647\u0630\u0627 \u0627\u0644\u0637\u0644\u0628 \u0645\u0637\u0644\u0648\u0628 \u0628\u0645\u0648\u062c\u0628 \u0642\u0627\u0646\u0648\u0646 \u062e\u062f\u0645\u0629 \u0627\u0644\u0635\u062d\u0629 \u0627\u0644\u0639\u0627\u0645\u0629 (PHS)\u060c \u0648\u064a\u0646\u0637\u0628\u0642 \u0639\u0644\u0649 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0645\u062b\u0644 \u0627\u0644\u0644\u0642\u0627\u062d\u0627\u062a\u060c \u0648\u0627\u0644\u0623\u062c\u0633\u0627\u0645 \u0627\u0644\u0645\u0636\u0627\u062f\u0629 \u0648\u062d\u064a\u062f\u0629 \u0627\u0644\u0646\u0633\u064a\u0644\u0629\u060c \u0648\u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u062c\u064a\u0646\u064a\u0629\u060c \u0648\u0627\u0644\u0639\u0644\u0627\u062c\u0627\u062a \u0627\u0644\u062e\u0644\u0648\u064a\u0629\u060c \u0648\u0627\u0644\u0628\u0631\u0648\u062a\u064a\u0646\u0627\u062a \u0627\u0644\u0645\u064f\u0639\u0627\u062f \u062a\u0631\u0643\u064a\u0628\u0647\u0627.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0648\u0628\u0639\u0628\u0627\u0631\u0627\u062a \u0628\u0633\u064a\u0637\u0629\u060c \u064a\u0648\u0636\u062d \u062a\u0631\u062e\u064a\u0635 \u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0627 \u0623\u0646 \u0627\u0644\u0645\u0646\u062a\u062c \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0622\u0645\u0646 \u0648\u0646\u0642\u064a \u0648\u0641\u0639\u0627\u0644 \u0644\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0645\u0642\u0635\u0648\u062f \u0645\u0646\u0647 \u0648\u0623\u0646\u0647 \u062a\u0645 \u062a\u0635\u0646\u064a\u0639\u0647 \u0648\u0641\u0642\u064b\u0627 \u0644\u0645\u0645\u0627\u0631\u0633\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0627\u0644\u062c\u064a\u062f\u0629 \u0627\u0644\u062d\u0627\u0644\u064a\u0629 (cGMP).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"why-is-a-bla-important\"><strong>\u0644\u0645\u0627\u0630\u0627 \u064a\u0639\u062a\u0628\u0631 BLA \u0645\u0647\u0645\u064b\u0627\u061f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u062a\u064f\u0639\u062f \u0639\u0645\u0644\u064a\u0629 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a (BLA) \u0623\u0633\u0627\u0633\u064a\u0629 \u0644\u0636\u0645\u0627\u0646 \u0627\u0633\u062a\u064a\u0641\u0627\u0621 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0627\u0644\u0645\u064f\u062a\u0627\u062d\u0629 \u0641\u064a \u0627\u0644\u0633\u0648\u0642 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u062c\u0648\u062f\u0629 \u0627\u0644\u0635\u0627\u0631\u0645\u0629. \u0639\u0627\u062f\u0629\u064b \u0645\u0627 \u062a\u0643\u0648\u0646 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0623\u0643\u062b\u0631 \u062a\u0639\u0642\u064a\u062f\u064b\u0627 \u0645\u0646 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u062a\u0642\u0644\u064a\u062f\u064a\u0629 \u0635\u063a\u064a\u0631\u0629 \u0627\u0644\u062c\u0632\u064a\u0626\u0627\u062a\u060c \u0648\u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u062a\u062a\u0636\u0645\u0646 \u062e\u0644\u0627\u064a\u0627 \u0623\u0648 \u0643\u0627\u0626\u0646\u0627\u062a \u062d\u064a\u0629 \u0641\u064a \u0639\u0645\u0644\u064a\u0629 \u062a\u0635\u0646\u064a\u0639\u0647\u0627. \u0648\u0646\u0638\u0631\u064b\u0627 \u0644\u0647\u0630\u0627 \u0627\u0644\u062a\u0639\u0642\u064a\u062f\u060c \u063a\u0627\u0644\u0628\u064b\u0627 \u0645\u0627 \u062a\u0643\u0648\u0646 \u0645\u0631\u0627\u062c\u0639\u0629 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a (BLA) \u0623\u0643\u062b\u0631 \u0634\u0645\u0648\u0644\u064b\u0627 \u0645\u0646 \u0639\u0645\u0644\u064a\u0629 \u0637\u0644\u0628 \u062f\u0648\u0627\u0621 \u062c\u062f\u064a\u062f (NDA).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u064a\u062a\u064a\u062d BLA \u0627\u0644\u0646\u0627\u062c\u062d \u0644\u0644\u0634\u0631\u0643\u0627\u062a \u0645\u0627 \u064a\u0644\u064a:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u062a\u0633\u0648\u064a\u0642 \u0648\u062a\u0648\u0632\u064a\u0639 \u0645\u0646\u062a\u062c\u0627\u062a\u0647\u0645 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629.<\/li>\n\n\n\n<li>\u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0627\u0644\u062d\u0635\u0631\u064a\u0629 \u0641\u064a \u0627\u0644\u0633\u0648\u0642 \u0644\u0641\u062a\u0631\u0629 \u0645\u0639\u064a\u0646\u0629.<\/li>\n\n\n\n<li>\u0644\u062a\u0639\u0632\u064a\u0632 \u0627\u0644\u0645\u0635\u062f\u0627\u0642\u064a\u0629 \u0645\u0639 \u0627\u0644\u0645\u0633\u062a\u062b\u0645\u0631\u064a\u0646 \u0648\u0645\u0642\u062f\u0645\u064a \u0627\u0644\u0631\u0639\u0627\u064a\u0629 \u0627\u0644\u0635\u062d\u064a\u0629 \u0648\u0627\u0644\u0645\u0631\u0636\u0649.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"key-components-of-a-biologics-license-application\"><strong>\u0627\u0644\u0645\u0643\u0648\u0646\u0627\u062a \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0644\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u062a\u0636\u0645\u0646 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0643\u0627\u0645\u0644 \u0643\u0645\u064a\u0629 \u0647\u0627\u0626\u0644\u0629 \u0645\u0646 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0645\u064f\u0648\u0644\u064e\u0651\u062f\u0629 \u062e\u0644\u0627\u0644 \u0627\u0644\u062a\u0637\u0648\u064a\u0631 \u0627\u0644\u0633\u0631\u064a\u0631\u064a \u0648\u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u060c \u0628\u0627\u0644\u0625\u0636\u0627\u0641\u0629 \u0625\u0644\u0649 \u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0648\u0645\u0631\u0627\u0642\u0628\u0629 \u0627\u0644\u062c\u0648\u062f\u0629. \u0627\u0644\u0645\u0643\u0648\u0646\u0627\u062a \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0647\u064a:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0625\u062f\u0627\u0631\u064a\u0629<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0627\u0633\u0645 \u0645\u0642\u062f\u0645 \u0627\u0644\u0637\u0644\u0628 \u0648\u0639\u0646\u0648\u0627\u0646\u0647 \u0648\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0627\u062a\u0635\u0627\u0644<\/li>\n\n\n\n<li>\u0627\u0633\u0645 \u0627\u0644\u0645\u0646\u062a\u062c \u0648\u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0645\u0644\u0643\u064a\u0629<\/li>\n\n\n\n<li>\u0634\u0647\u0627\u062f\u0627\u062a \u0628\u0631\u0627\u0621\u0627\u062a \u0627\u0644\u0627\u062e\u062a\u0631\u0627\u0639 \u0648\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u062a\u0633\u0645\u064a\u0629<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u062f\u0631\u0627\u0633\u0627\u062a \u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0633\u0645\u064a\u0629 \u063a\u064a\u0631 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629<\/li>\n\n\n\n<li>\u0628\u064a\u0627\u0646\u0627\u062a \u0639\u0644\u0645 \u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0648\u0622\u0644\u064a\u0629 \u0627\u0644\u0639\u0645\u0644<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0646\u062a\u0627\u0626\u062c \u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0644\u0645\u0631\u062d\u0644\u0629 1 \u06482 \u06483<\/li>\n\n\n\n<li>\u0627\u0644\u062a\u062d\u0644\u064a\u0644\u0627\u062a \u0627\u0644\u0625\u062d\u0635\u0627\u0626\u064a\u0629 \u0627\u0644\u062a\u064a \u062a\u0648\u0636\u062d \u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629 \u0648\u0627\u0644\u0633\u0644\u0627\u0645\u0629<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0627\u0644\u0643\u064a\u0645\u064a\u0627\u0621 \u0648\u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0648\u0627\u0644\u0636\u0648\u0627\u0628\u0637 (CMC)<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u062a\u0641\u0627\u0635\u064a\u0644 \u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0648\u0627\u0644\u0645\u0646\u0634\u0623\u0629<\/li>\n\n\n\n<li>\u0625\u062c\u0631\u0627\u0621\u0627\u062a \u0636\u0645\u0627\u0646 \u0627\u0644\u062c\u0648\u062f\u0629 \u0648\u0627\u0644\u0627\u062e\u062a\u0628\u0627\u0631<\/li>\n\n\n\n<li>\u0633\u062c\u0644\u0627\u062a \u0627\u0644\u062f\u0641\u0639\u0627\u062a \u0648\u0627\u0644\u0645\u0648\u0627\u0635\u0641\u0627\u062a \u0648\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u062a\u062d\u0642\u0642<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0648\u0636\u0639 \u0627\u0644\u0639\u0644\u0627\u0645\u0627\u062a \u0648\u0627\u0644\u062a\u063a\u0644\u064a\u0641<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0648\u0635\u0641\u0629 \u0627\u0644\u0645\u0642\u062a\u0631\u062d\u0629<\/li>\n\n\n\n<li>\u062a\u0635\u0645\u064a\u0645 \u0627\u0644\u0639\u0628\u0648\u0627\u062a \u0648\u0646\u0634\u0631\u0627\u062a \u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0644\u0644\u0645\u0631\u064a\u0636<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>\u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0628\u064a\u0626\u064a\u0629 \u0648\u0627\u0644\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u0645\u062a\u0639\u0644\u0642\u0629 \u0628\u0627\u0644\u0645\u0646\u0634\u0623\u0629<\/strong>\n<ul class=\"wp-block-list\">\n<li>\u0627\u0644\u062a\u0642\u064a\u064a\u0645\u0627\u062a \u0627\u0644\u0628\u064a\u0626\u064a\u0629<\/li>\n\n\n\n<li>\u0648\u062b\u0627\u0626\u0642 \u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u062a\u0641\u062a\u064a\u0634<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"the-bla-review-and-approval-process\"><strong>\u0639\u0645\u0644\u064a\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 \u0648\u0627\u0639\u062a\u0645\u0627\u062f BLA<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u0642\u0648\u0645 \u0645\u0631\u0643\u0632 \u062a\u0642\u064a\u064a\u0645 \u0648\u0623\u0628\u062d\u0627\u062b \u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (CBER) \u0623\u0648 \u0645\u0631\u0643\u0632 \u062a\u0642\u064a\u064a\u0645 \u0648\u0623\u0628\u062d\u0627\u062b \u0627\u0644\u0623\u062f\u0648\u064a\u0629 (CDER) \u0627\u0644\u062a\u0627\u0628\u0639 \u0644\u0640 FDA \u0628\u0645\u0631\u0627\u062c\u0639\u0629 \u0637\u0644\u0628\u0627\u062a \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a (BLAs) \u062d\u0633\u0628 \u0646\u0648\u0639 \u0627\u0644\u0645\u0646\u062a\u062c. \u0648\u062a\u062a\u0645 \u0627\u0644\u0639\u0645\u0644\u064a\u0629 \u0639\u0627\u062f\u0629\u064b \u0639\u0644\u0649 \u0627\u0644\u0646\u062d\u0648 \u0627\u0644\u062a\u0627\u0644\u064a:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>\u0627\u062c\u062a\u0645\u0627\u0639 \u0645\u0627 \u0642\u0628\u0644 BLA<\/strong><br>\u064a\u062c\u062a\u0645\u0639 \u0627\u0644\u0631\u0639\u0627\u0629 \u0645\u0639 FDA \u0644\u0645\u0646\u0627\u0642\u0634\u0629 \u062c\u0627\u0647\u0632\u064a\u0629 \u0627\u0644\u062a\u0642\u062f\u064a\u0645 \u0648\u062a\u0648\u0636\u064a\u062d \u0627\u0644\u062a\u0648\u0642\u0639\u0627\u062a \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629.<\/li>\n\n\n\n<li><strong>\u0645\u0631\u0627\u062c\u0639\u0629 \u062a\u0642\u062f\u064a\u0645 \u0648\u0625\u064a\u062f\u0627\u0639 \u0637\u0644\u0628 BLA<\/strong><br>\u064a\u0642\u0648\u0645 FDA \u0628\u0625\u062c\u0631\u0627\u0621 \u0645\u0631\u0627\u062c\u0639\u0629 \u0644\u0644\u0645\u0644\u0641 \u0644\u0645\u062f\u0629 60 \u064a\u0648\u0645\u064b\u0627 \u0644\u062a\u062d\u062f\u064a\u062f \u0645\u0627 \u0625\u0630\u0627 \u0643\u0627\u0646 \u0627\u0644\u0637\u0644\u0628 \u0645\u0643\u062a\u0645\u0644\u064b\u0627 \u0628\u062f\u0631\u062c\u0629 \u0643\u0627\u0641\u064a\u0629 \u0644\u0644\u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u062a\u0641\u0635\u064a\u0644\u064a.<\/li>\n\n\n\n<li><strong>\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0634\u0627\u0645\u0644\u0629<\/strong><br>\u062a\u0631\u0627\u062c\u0639 \u0627\u0644\u0648\u0643\u0627\u0644\u0629 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629\u060c \u0648\u0645\u0639\u0644\u0648\u0645\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639\u060c \u0648\u0627\u0644\u062a\u0633\u0645\u064a\u0627\u062a. \u0648\u0642\u062f \u062a\u064f\u062c\u0631\u064a \u0639\u0645\u0644\u064a\u0627\u062a \u062a\u0641\u062a\u064a\u0634 \u0644\u0645\u0648\u0627\u0642\u0639 \u0627\u0644\u062a\u0635\u0646\u064a\u0639.<\/li>\n\n\n\n<li><strong>\u0627\u062c\u062a\u0645\u0627\u0639 \u0627\u0644\u0644\u062c\u0646\u0629 \u0627\u0644\u0627\u0633\u062a\u0634\u0627\u0631\u064a\u0629 (\u0625\u0646 \u0648\u062c\u062f)<\/strong><br>\u064a\u0645\u0643\u0646 \u0644\u062e\u0628\u0631\u0627\u0621 \u0645\u0633\u062a\u0642\u0644\u064a\u0646 \u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0637\u0644\u0628 \u0648\u062a\u0642\u062f\u064a\u0645 \u0627\u0644\u062a\u0648\u0635\u064a\u0627\u062a.<\/li>\n\n\n\n<li><strong>\u0642\u0631\u0627\u0631 FDA<\/strong><br>\u064a\u0635\u062f\u0631 \u0627\u0644\u0646\u0645\u0648\u0630\u062c FDA \u0625\u0645\u0627 \u062e\u0637\u0627\u0628 \u0645\u0648\u0627\u0641\u0642\u0629 \u0623\u0648 \u062e\u0637\u0627\u0628 \u0627\u0633\u062a\u062c\u0627\u0628\u0629 \u0643\u0627\u0645\u0644 (CRL) \u064a\u0648\u0636\u062d \u0623\u0648\u062c\u0647 \u0627\u0644\u0642\u0635\u0648\u0631 \u0627\u0644\u062a\u064a \u064a\u062c\u0628 \u0645\u0639\u0627\u0644\u062c\u062a\u0647\u0627.<\/li>\n\n\n\n<li><strong>\u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629<\/strong><br>\u0642\u062f \u064a\u062d\u062a\u0627\u062c \u0627\u0644\u0631\u0639\u0627\u0629 \u0625\u0644\u0649 \u0625\u062c\u0631\u0627\u0621 \u062f\u0631\u0627\u0633\u0627\u062a \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642 \u0623\u0648 \u0627\u0644\u062a\u0632\u0627\u0645\u0627\u062a \u0627\u0644\u0645\u0631\u062d\u0644\u0629 \u0627\u0644\u0631\u0627\u0628\u0639\u0629.<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"bla-vs-nda-whats-the-difference\"><strong>BLA \u0645\u0642\u0627\u0628\u0644 NDA: \u0645\u0627 \u0647\u0648 \u0627\u0644\u0641\u0631\u0642\u061f<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0639\u0644\u0649 \u0627\u0644\u0631\u063a\u0645 \u0645\u0646 \u0623\u0646 \u0643\u0644 \u0645\u0646 BLAs \u0648 NDAs \u0647\u064a \u0645\u0633\u0627\u0631\u0627\u062a \u0644\u0644\u062d\u0635\u0648\u0644 \u0639\u0644\u0649 \u0645\u0648\u0627\u0641\u0642\u0629 FDA\u060c \u0625\u0644\u0627 \u0623\u0646\u0647\u0627 \u062a\u062e\u062a\u0644\u0641 \u0628\u0646\u0627\u0621\u064b \u0639\u0644\u0649 \u0646\u0648\u0639 \u0627\u0644\u0645\u0646\u062a\u062c:<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>\u0648\u062c\u0647<\/strong><\/th><th><strong>BLA (\u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629)<\/strong><\/th><th><strong>NDA (\u0627\u0644\u0645\u062e\u062f\u0631\u0627\u062a)<\/strong><\/th><\/tr><\/thead><tbody><tr><td>\u0627\u0644\u0647\u064a\u0626\u0629 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a\u0629<\/td><td>\u0642\u0627\u0646\u0648\u0646 \u062e\u062f\u0645\u0627\u062a \u0627\u0644\u0635\u062d\u0629 \u0627\u0644\u0639\u0627\u0645\u0629<\/td><td>\u0642\u0627\u0646\u0648\u0646 \u0627\u0644\u063a\u0630\u0627\u0621 \u0648\u0627\u0644\u062f\u0648\u0627\u0621 \u0648\u0645\u0633\u062a\u062d\u0636\u0631\u0627\u062a \u0627\u0644\u062a\u062c\u0645\u064a\u0644 \u0627\u0644\u0641\u064a\u062f\u0631\u0627\u0644\u064a<\/td><\/tr><tr><td>\u0646\u0648\u0639 \u0627\u0644\u0645\u0646\u062a\u062c<\/td><td>\u0627\u0644\u0645\u0648\u0627\u062f \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (\u0627\u0644\u0628\u0631\u0648\u062a\u064a\u0646\u0627\u062a \u0648\u0627\u0644\u062e\u0644\u0627\u064a\u0627 \u0648\u0627\u0644\u0644\u0642\u0627\u062d\u0627\u062a)<\/td><td>\u0627\u0644\u0623\u062f\u0648\u064a\u0629 \u0627\u0644\u062c\u0632\u064a\u0626\u064a\u0629 \u0627\u0644\u0635\u063a\u064a\u0631\u0629<\/td><\/tr><tr><td>\u0642\u0633\u0645 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629<\/td><td>CBER \u0623\u0648 CDER<\/td><td>\u0645\u0631\u0643\u0632 \u062a\u0642\u064a\u064a\u0645 \u0627\u0644\u0623\u062b\u0631 \u0627\u0644\u0628\u064a\u0626\u064a<\/td><\/tr><tr><td>\u0627\u0644\u062a\u0631\u0643\u064a\u0632 \u0639\u0644\u0649 \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629<\/td><td>\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0646\u0642\u0627\u0621 \u0648\u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629<\/td><td>\u0627\u0644\u0633\u0644\u0627\u0645\u0629 \u0648\u0627\u0644\u0641\u0639\u0627\u0644\u064a\u0629<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"electronic-bla-e-bla-submissions\"><strong>\u0625\u0631\u0633\u0627\u0644\u064a\u0627\u062a BLA \u0627\u0644\u0625\u0644\u0643\u062a\u0631\u0648\u0646\u064a\u0629 (eBLA)<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u0634\u062c\u0639 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 FDA \u0639\u0644\u0649 \u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u062a\u0642\u062f\u064a\u0645\u0627\u062a \u0627\u0644\u0625\u0644\u0643\u062a\u0631\u0648\u0646\u064a\u0629 \u0628\u0635\u064a\u063a\u0629 eCTD (\u0627\u0644\u0648\u062b\u064a\u0642\u0629 \u0627\u0644\u0641\u0646\u064a\u0629 \u0627\u0644\u0625\u0644\u0643\u062a\u0631\u0648\u0646\u064a\u0629 \u0627\u0644\u0645\u0634\u062a\u0631\u0643\u0629). \u064a\u0636\u0645\u0646 \u0647\u0630\u0627 \u0627\u0644\u0645\u0639\u064a\u0627\u0631 \u0627\u0644\u0627\u062a\u0633\u0627\u0642 \u0648\u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u0627\u0644\u062a\u062a\u0628\u0639 \u0648\u0633\u0647\u0648\u0644\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0641\u064a \u062c\u0645\u064a\u0639 \u0645\u0643\u0648\u0646\u0627\u062a \u0627\u062a\u0641\u0627\u0642\u064a\u0629 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0633\u062a\u062e\u062f\u0645 \u0627\u0644\u0646\u0647\u0627\u0626\u064a.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u062a\u062a\u0636\u0645\u0646 \u0627\u0644\u0641\u0648\u0627\u0626\u062f \u0627\u0644\u0631\u0626\u064a\u0633\u064a\u0629 \u0644\u0640 eBLA \u0645\u0627 \u064a\u0644\u064a:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u062a\u0648\u0627\u0635\u0644 \u0645\u0628\u0633\u0637 \u0645\u0639 FDA<\/li>\n\n\n\n<li>\u062a\u062e\u0641\u064a\u0641 \u0627\u0644\u0639\u0628\u0621 \u0627\u0644\u0625\u062f\u0627\u0631\u064a<\/li>\n\n\n\n<li>\u0645\u0648\u0627\u0639\u064a\u062f \u0645\u0631\u0627\u062c\u0639\u0629 \u0623\u0633\u0631\u0639<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"bla-supplements-and-amendments\"><strong>\u0645\u0644\u0627\u062d\u0642 \u0648\u062a\u0639\u062f\u064a\u0644\u0627\u062a \u0642\u0627\u0646\u0648\u0646 BLA<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u0628\u0645\u062c\u0631\u062f \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629 \u0639\u0644\u0649 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0628\u064a\u0648\u0644\u0648\u062c\u064a \u062c\u062f\u064a\u062f\u060c \u0642\u062f \u064a\u062d\u062a\u0627\u062c \u0627\u0644\u0645\u0635\u0646\u0639\u0648\u0646 \u0625\u0644\u0649 \u0625\u062c\u0631\u0627\u0621 \u062a\u063a\u064a\u064a\u0631\u0627\u062a \u0628\u0639\u062f \u0627\u0644\u0645\u0648\u0627\u0641\u0642\u0629\u060c \u0645\u062b\u0644:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0645\u0624\u0634\u0631\u0627\u062a \u0623\u0648 \u0623\u0634\u0643\u0627\u0644 \u062c\u0631\u0639\u0627\u062a \u062c\u062f\u064a\u062f\u0629<\/li>\n\n\n\n<li>\u062a\u063a\u064a\u064a\u0631\u0627\u062a \u0645\u0648\u0642\u0639 \u0627\u0644\u062a\u0635\u0646\u064a\u0639<\/li>\n\n\n\n<li>\u062a\u062d\u062f\u064a\u062b\u0627\u062a \u0627\u0644\u0648\u0633\u0645<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u062a\u062a\u0637\u0644\u0628 \u0647\u0630\u0647 \u0627\u0644\u062a\u0639\u062f\u064a\u0644\u0627\u062a \u0645\u0643\u0645\u0644\u0627\u062a BLA\u060c \u0648\u0627\u0644\u062a\u064a \u062a\u062a\u0645 \u0645\u0631\u0627\u062c\u0639\u062a\u0647\u0627 \u0628\u0634\u0643\u0644 \u0645\u0646\u0641\u0635\u0644 \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u062a\u0623\u062b\u064a\u0631\u0647\u0627 \u0639\u0644\u0649 \u062c\u0648\u062f\u0629 \u0627\u0644\u0645\u0646\u062a\u062c \u0623\u0648 \u0633\u0644\u0627\u0645\u062a\u0647.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"tips-for-a-successful-bla-submission\"><strong>\u0646\u0635\u0627\u0626\u062d \u0644\u062a\u0642\u062f\u064a\u0645 \u0637\u0644\u0628 BLA \u0646\u0627\u062c\u062d<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u0627\u0646\u062e\u0631\u0637 \u0645\u0628\u0643\u0631\u064b\u0627 \u0645\u0639 FDA:<\/strong> \u062c\u062f\u0648\u0644\u0629 \u0627\u062c\u062a\u0645\u0627\u0639\u0627\u062a \u0645\u0627 \u0642\u0628\u0644 BLA \u0648\u062a\u0648\u0636\u064a\u062d \u0627\u0644\u062a\u0648\u0642\u0639\u0627\u062a.<\/li>\n\n\n\n<li><strong>\u0627\u0644\u062d\u0641\u0627\u0638 \u0639\u0644\u0649 \u0627\u0644\u0648\u062b\u0627\u0626\u0642 \u0627\u0644\u0643\u0627\u0645\u0644\u0629:<\/strong> \u0636\u0645\u0627\u0646 \u0633\u0644\u0627\u0645\u0629 \u0627\u0644\u0628\u064a\u0627\u0646\u0627\u062a \u0648\u0625\u0645\u0643\u0627\u0646\u064a\u0629 \u062a\u062a\u0628\u0639\u0647\u0627 \u0639\u0628\u0631 \u0627\u0644\u0623\u0642\u0633\u0627\u0645 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0648\u0645\u0627 \u0642\u0628\u0644 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0648\u0627\u0644\u062a\u0635\u0646\u064a\u0639\u064a\u0629.<\/li>\n\n\n\n<li><strong>\u0627\u0644\u062a\u0631\u0643\u064a\u0632 \u0639\u0644\u0649 \u062c\u0627\u0647\u0632\u064a\u0629 CMC:<\/strong> \u062a\u0639\u062f \u0645\u0634\u0643\u0644\u0627\u062a \u0627\u0644\u062a\u0635\u0646\u064a\u0639 \u0645\u0646 \u0628\u064a\u0646 \u0627\u0644\u0623\u0633\u0628\u0627\u0628 \u0627\u0644\u0623\u0643\u062b\u0631 \u0634\u064a\u0648\u0639\u064b\u0627 \u0644\u062a\u0623\u062e\u064a\u0631 BLA.<\/li>\n\n\n\n<li><strong>\u062e\u0637\u0629 \u0627\u0644\u062a\u0641\u062a\u064a\u0634:<\/strong> \u0643\u0646 \u0645\u0633\u062a\u0639\u062f\u064b\u0627 \u0644\u0644\u062a\u062f\u0642\u064a\u0642 \u0648\u0627\u062d\u062a\u0641\u0638 \u0628\u0633\u062c\u0644\u0627\u062a \u0645\u0641\u0635\u0644\u0629 \u0644\u0644\u0645\u0631\u0627\u0641\u0642 \u0648\u0627\u0644\u062f\u0641\u0639\u0627\u062a.<\/li>\n\n\n\n<li><strong>\u0627\u0633\u062a\u0641\u062f \u0645\u0646 \u0645\u0633\u062a\u0634\u0627\u0631\u064a \u0627\u0644\u062a\u0646\u0638\u064a\u0645:<\/strong> \u064a\u0645\u0643\u0646 \u0644\u0644\u062e\u0628\u0631\u0627\u0621 \u0630\u0648\u064a \u0627\u0644\u062e\u0628\u0631\u0629 \u0645\u0633\u0627\u0639\u062f\u062a\u0643 \u0641\u064a \u0627\u0644\u062a\u0646\u0642\u0644 \u0628\u064a\u0646 \u0645\u062a\u0637\u0644\u0628\u0627\u062a FDA \u0648\u062a\u0641\u0627\u0635\u064a\u0644 \u0627\u0644\u0625\u0631\u0633\u0627\u0644.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"fa-qs-about-bl-as\"><strong>\u0627\u0644\u0623\u0633\u0626\u0644\u0629 \u0627\u0644\u0634\u0627\u0626\u0639\u0629 \u062d\u0648\u0644 BLAs<\/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\">\u0645\u0646 \u064a\u0631\u0627\u062c\u0639 BLAs \u0641\u064a FDA\u061f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u064a\u062a\u0645 \u0645\u0631\u0627\u062c\u0639\u0629 \u0637\u0644\u0628\u0627\u062a \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0627\u0633\u062a\u062e\u062f\u0627\u0645 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a \u0625\u0645\u0627 \u0645\u0646 \u0642\u0628\u0644 CBER \u0623\u0648 CDER\u060c \u0627\u0639\u062a\u0645\u0627\u062f\u064b\u0627 \u0639\u0644\u0649 \u0646\u0648\u0639 \u0627\u0644\u0645\u0627\u062f\u0629 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0648\u0645\u0624\u0634\u0631\u0647\u0627.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183249315\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u0643\u0645 \u0645\u0646 \u0627\u0644\u0648\u0642\u062a \u062a\u0633\u062a\u063a\u0631\u0642 \u0639\u0645\u0644\u064a\u0629 \u0645\u0631\u0627\u062c\u0639\u0629 BLA\u061f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u0627\u0644\u0645\u062f\u0629 \u0627\u0644\u0642\u064a\u0627\u0633\u064a\u0629 \u0644\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0647\u064a 10 \u0623\u0634\u0647\u0631\u060c \u0641\u064a \u062d\u064a\u0646 \u0623\u0646 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629 \u0627\u0644\u0623\u0648\u0644\u0648\u064a\u0629 \u0642\u062f \u062a\u062e\u062a\u0635\u0631\u0647\u0627 \u0625\u0644\u0649 6 \u0623\u0634\u0647\u0631.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183275484\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u0647\u0644 \u064a\u0645\u0643\u0646 \u0633\u062d\u0628 BLA\u061f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u0646\u0639\u0645\u060c \u064a\u0645\u0643\u0646 \u0644\u0644\u0631\u0639\u0627\u0629 \u0633\u062d\u0628 \u0637\u0644\u0628 BLA \u0637\u0648\u0627\u0639\u064a\u0629 \u0641\u064a \u0623\u064a \u0648\u0642\u062a \u0642\u0628\u0644 \u0623\u0648 \u0628\u0639\u062f \u0645\u0631\u0627\u062c\u0639\u0629 FDA.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1762183285301\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u0645\u0627\u0630\u0627 \u064a\u062d\u062f\u062b \u0628\u0639\u062f \u0645\u0648\u0627\u0641\u0642\u0629 BLA\u061f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u064a\u062a\u0639\u064a\u0646 \u0639\u0644\u0649 \u0627\u0644\u0634\u0631\u0643\u0627\u062a \u0627\u0644\u0645\u0635\u0646\u0639\u0629 \u0627\u0644\u0627\u0644\u062a\u0632\u0627\u0645 \u0628\u0645\u0631\u0627\u0642\u0628\u0629 \u0645\u0627 \u0628\u0639\u062f \u0627\u0644\u062a\u0633\u0648\u064a\u0642\u060c \u0648\u0625\u0639\u062f\u0627\u062f \u0627\u0644\u062a\u0642\u0627\u0631\u064a\u0631 \u0627\u0644\u062f\u0648\u0631\u064a\u0629 \u0639\u0646 \u0627\u0644\u0633\u0644\u0627\u0645\u0629\u060c \u0648\u0623\u064a \u062f\u0631\u0627\u0633\u0627\u062a \u0625\u0636\u0627\u0641\u064a\u0629 \u0645\u0641\u0631\u0648\u0636\u0629 \u0628\u0645\u0648\u062c\u0628 FDA.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"conclusion\"><strong>\u062e\u0627\u062a\u0645\u0629<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u064a\u064f\u0639\u062f \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 (BLA) \u062d\u062c\u0631 \u0627\u0644\u0623\u0633\u0627\u0633 \u0641\u064a \u0627\u0644\u0645\u0633\u0627\u0631 \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0644\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u0641\u064a \u0627\u0644\u0648\u0644\u0627\u064a\u0627\u062a \u0627\u0644\u0645\u062a\u062d\u062f\u0629. \u0645\u0646 \u062e\u0644\u0627\u0644 \u0641\u0647\u0645 \u0647\u064a\u0643\u0644 \u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0645\u0646\u062a\u062c\u0627\u062a \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629\u060c \u0648\u0645\u062a\u0637\u0644\u0628\u0627\u062a \u0627\u0644\u062a\u0642\u062f\u064a\u0645\u060c \u0648\u0639\u0645\u0644\u064a\u0629 \u0627\u0644\u0645\u0631\u0627\u062c\u0639\u0629\u060c \u064a\u064f\u0645\u0643\u0646 \u0644\u0644\u062c\u0647\u0627\u062a \u0627\u0644\u0631\u0627\u0639\u064a\u0629 \u062a\u0628\u0633\u064a\u0637 \u0639\u0645\u0644\u064a\u0629 \u0637\u0631\u062d \u0645\u0646\u062a\u062c\u0627\u062a\u0647\u0627 \u0641\u064a \u0627\u0644\u0633\u0648\u0642 \u0645\u0639 \u0636\u0645\u0627\u0646 \u0627\u0644\u0627\u0645\u062a\u062b\u0627\u0644 \u0644\u0645\u0639\u0627\u064a\u064a\u0631 FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0633\u0648\u0627\u0621 \u0643\u0627\u0646 \u0627\u0644\u0623\u0645\u0631 \u064a\u062a\u0639\u0644\u0642 \u0628\u062a\u0637\u0648\u064a\u0631 \u0644\u0642\u0627\u062d\u060c \u0623\u0648 \u0639\u0644\u0627\u062c \u062c\u064a\u0646\u064a\u060c \u0623\u0648 \u0623\u062c\u0633\u0627\u0645 \u0645\u0636\u0627\u062f\u0629 \u0648\u062d\u064a\u062f\u0629 \u0627\u0644\u0646\u0633\u064a\u0644\u0629\u060c \u0641\u0625\u0646 \u0627\u0644\u0625\u0639\u062f\u0627\u062f \u0627\u0644\u062f\u0642\u064a\u0642 \u0644\u0637\u0644\u0628 \u062a\u0631\u062e\u064a\u0635 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0627 \u0627\u0644\u0628\u064a\u0648\u0644\u0648\u062c\u064a\u0629 \u064a\u0645\u0643\u0646 \u0623\u0646 \u064a\u0639\u0646\u064a \u0627\u0644\u0641\u0627\u0631\u0642 \u0628\u064a\u0646 \u0627\u0644\u0646\u062c\u0627\u062d \u0627\u0644\u062a\u0646\u0638\u064a\u0645\u064a \u0648\u0627\u0644\u062a\u0623\u062e\u064a\u0631 \u0627\u0644\u0645\u0643\u0644\u0641.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0627\u0642\u0631\u0623 \u0627\u0644\u0645\u0632\u064a\u062f<\/strong>:\u00a0<a href=\"https:\/\/dmdwarrior.com\/ar\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u0627\u0644\u062a\u062c\u0627\u0631\u0628 \u0627\u0644\u0633\u0631\u064a\u0631\u064a\u0629 \u0644\u0645\u0631\u0636 \u062f\u0648\u0634\u064a\u0646 (\u0642\u0627\u0626\u0645\u0629 \u0628\u062c\u0645\u064a\u0639 \u0627\u0644\u0623\u0628\u062d\u0627\u062b)<\/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\/ar\/wp-json\/wp\/v2\/posts\/5027","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/comments?post=5027"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/posts\/5027\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media\/5030"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/media?parent=5027"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/categories?post=5027"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/ar\/wp-json\/wp\/v2\/tags?post=5027"}],"curies":[{"name":"\u0648\u0648\u0631\u062f\u0628\u0631\u064a\u0633","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}