List of Relevant Quality Guidances & Common Deficiencies Observed during DMF Review

  Рет қаралды 1,855

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

Submit proposed questions on this poster to DMFWorkshop2021@fda.hhs.gov by March 19, 2021, and tune in for the subsequent panel discussion during the Drug Master File (DMF) and Drug Substance follow-up webinar on April 9, 2021.
To review posters and register for the webinar, visit: www.fda.gov/dr...
This poster provides a non-exhaustive list of relevant technical guidance applicable to DMFs and common deficiencies.
To view all posters and conference presentations, visit: www.fda.gov/dr...
To listen to a Q&A on poster and conference topics, visit: www.fda.gov/dr...
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.    
Upcoming Training - www.fda.gov/cd...
SBIA Listserv - public.govdeli...
SBIA 2021 Playlist - • 2021 CDER Small Busine...
SBIA LinkedIn: / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cd...
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

Пікірлер
Timeline for the Drug Master Review Process
22:08
U.S. Food and Drug Administration
Рет қаралды 4,4 М.
Administrative Aspects of Managing a Drug Master File (DMF)
23:56
U.S. Food and Drug Administration
Рет қаралды 3,4 М.
龟兔赛跑:好可爱的小乌龟#short #angel #clown
01:00
Super Beauty team
Рет қаралды 101 МЛН
Человек паук уже не тот
00:32
Miracle
Рет қаралды 2,8 МЛН
Não sabe esconder Comida
00:20
DUDU e CAROL
Рет қаралды 58 МЛН
Cool Parenting Gadget Against Mosquitos! 🦟👶 #gen
00:21
TheSoul Music Family
Рет қаралды 33 МЛН
Effective Communication Strategies for Drug Master Files (DMF)
31:31
U.S. Food and Drug Administration
Рет қаралды 1,3 М.
The Drug Master File (DMF) Teleconference Process
15:51
U.S. Food and Drug Administration
Рет қаралды 980
October 31, 2024 Endocrinologic and Metabolic Drugs Advisory Committee
U.S. Food and Drug Administration
Рет қаралды 419
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 2 - Part 1
1:31:22
CMC Considerations for CAR T Cell Product Development
29:42
U.S. Food and Drug Administration
Рет қаралды 12 М.
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 1
1:33:53
ICH M12 Drug-Drug Interaction Studies Final Guidance
1:54:10
U.S. Food and Drug Administration
Рет қаралды 623
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 1 - Part 2
1:12:08
Advancing Generic Drug Development: Translating Science to Approval 2024 - Day 2 - Part 2
1:39:03
龟兔赛跑:好可爱的小乌龟#short #angel #clown
01:00
Super Beauty team
Рет қаралды 101 МЛН