Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 9:26 4 years ago 3 139 Скачать Далее
Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 14:56 4 years ago 491 Скачать Далее
ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 19:24 4 years ago 1 381 Скачать Далее
ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 31:34 4 years ago 698 Скачать Далее
Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 15:00 4 years ago 524 Скачать Далее
GDUFA II (9/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 19:43 4 years ago 793 Скачать Далее
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 19:20 4 years ago 1 497 Скачать Далее
Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 20:23 4 years ago 453 Скачать Далее
ANDA Program Performance Review and Tips (8of16) Generic Drugs Forum 2020 U.S. Food and Drug Administration 38:23 4 years ago 1 394 Скачать Далее
OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 17:27 4 years ago 327 Скачать Далее
Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 31:44 4 years ago 1 229 Скачать Далее
Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 20:47 4 years ago 486 Скачать Далее
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 17:24 4 years ago 307 Скачать Далее
Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 16:07 4 years ago 568 Скачать Далее
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 1 432 Скачать Далее
GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 23:46 4 years ago 614 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 1 035 Скачать Далее
eCTD (7/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 17:16 4 years ago 668 Скачать Далее
OPQ Communications with Industry (21/28) Generic Drugs Forum 2017 U.S. Food and Drug Administration 15:59 4 years ago 417 Скачать Далее
Good ANDA Submission and Assessment Practices and Software Support (5of27) Generic Drugs Forum 2018 U.S. Food and Drug Administration 11:47 4 years ago 2 487 Скачать Далее