U.S. Food and Drug Administration | Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 2 @US_FDA | Uploaded 2 months ago | Updated 12 hours ago
The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.
Timestamps
00:08 – Nitrosamine Risk Assessment in Type II Drug Master Files (DMFs) Supporting GDUFA Applications
21:13 – Post approval changes in Complex Generics from Drug Product/Chemistry Manufacturing & Controls (CMC) Perspectives
46:0017 – Quality Considerations for Topical Ophthalmic Drug Products - Guidance for Industry
01:07:38 – Q&A Discussion Panel
Speakers | Panelists:
Govindaraj Kumaran, PhD
Chemist
Division of Product Quality Assessment XIX (DPQA XIX)
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA
David Awotwe-Otoo, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment III (DPQA III)
Office of Product Quality Assessment I (OPQA I)
OPQ | CDER | FDA
Asif Rasheed, PhD
Senior Review Chemist
Division of Product Quality Assessment VIII (DPQA VIII)
Office of Product Quality Assessment II (OPQA II)
OPQ | CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024
-----------------------
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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
The Generic Drugs Forum is an annual, two-day event with the goal of providing practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.
Timestamps
00:08 – Nitrosamine Risk Assessment in Type II Drug Master Files (DMFs) Supporting GDUFA Applications
21:13 – Post approval changes in Complex Generics from Drug Product/Chemistry Manufacturing & Controls (CMC) Perspectives
46:0017 – Quality Considerations for Topical Ophthalmic Drug Products - Guidance for Industry
01:07:38 – Q&A Discussion Panel
Speakers | Panelists:
Govindaraj Kumaran, PhD
Chemist
Division of Product Quality Assessment XIX (DPQA XIX)
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA
David Awotwe-Otoo, PhD
Senior Pharmaceutical Quality Assessor
Division of Product Quality Assessment III (DPQA III)
Office of Product Quality Assessment I (OPQA I)
OPQ | CDER | FDA
Asif Rasheed, PhD
Senior Review Chemist
Division of Product Quality Assessment VIII (DPQA VIII)
Office of Product Quality Assessment II (OPQA II)
OPQ | CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024
-----------------------
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 - fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2024 Playlist - youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g
SBIA LinkedIn - linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - fda.gov/cdersbialearn
Twitter - twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
