Referencing Approved Drug Products in ANDA Submissions (9of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 16:19 4 years ago 1 448 Скачать Далее
Referencing Approved Drug Products in ANDA Submissions U.S. Food and Drug Administration 39:41 3 years ago 8 186 Скачать Далее
Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 42:28 4 years ago 1 798 Скачать Далее
Orange Book - Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 16:29 4 years ago 937 Скачать Далее
505(b)(2) NDA or ANDA? (10of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 20:08 4 years ago 5 052 Скачать Далее
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions U.S. Food and Drug Administration 13:58 3 years ago 1 878 Скачать Далее
Assessment Tips (17of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 14:24 4 years ago 171 Скачать Далее
Complex Product Development (3of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 23:10 4 years ago 658 Скачать Далее
Questions and Answers (28of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 10:36 4 years ago 635 Скачать Далее
Questions and Answers (11of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 27:46 4 years ago 668 Скачать Далее
Pre-ANDA Meeting or Controlled Correspondence? (4of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 19:49 4 years ago 1 042 Скачать Далее
Questions and Answers (15of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 15:46 4 years ago 245 Скачать Далее
Filing and Refuse to Receive (RTR) (16of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 21:56 4 years ago 799 Скачать Далее
Keynote: Generic Drug Program Update (1of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 20:05 4 years ago 343 Скачать Далее
Questions and Answers (23of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 23:55 4 years ago 238 Скачать Далее
Questions and Answers (5of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 3:23 4 years ago 250 Скачать Далее
Impurity Case Studies: Pharmacology/Toxicology (22of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 25:40 4 years ago 1 707 Скачать Далее
Update on Technical Rejection Criteria for Study Data (14of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 19:35 4 years ago 239 Скачать Далее
Practical Tips on eCTD (13of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 23:35 4 years ago 923 Скачать Далее
Questions and Answers (19of28) Generic Drugs Forum – Apr. 3-4, 2019 U.S. Food and Drug Administration 33:04 4 years ago 178 Скачать Далее
