U.S. Food and Drug Administration | Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 2, Pt 4 @US_FDA | Uploaded 2 months ago | Updated 10 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
00:07 – Improving the Sterility Assurance Application to the FDA
17:57 – The Bacterial Endotoxins Specification - Points to Consider
36:16 – General Overview of ANDAs Labeling Requirements for Rx to OTC Switched Products
43:42 – Pending Applications
51:09 – Regulatory Reminders at the Finish Line
56:28 – Areas for Improvement
01:09:20 – Q&A Discussion Panel
01:23:33 – Closing Remarks
Speakers | Panelists:
John Arigo, PhD
Division Director
Division of Pharmaceutical Manufacturing Assessment (DPMA II)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA
Erika Pfeiler, PhD
Unit Supervisor
Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)
OPMA | OPQ | CDER | FDA
Bayli Larson, PharmD
Pharmacist
Patent and Exclusivity Team (PET)
Division of Legal & Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP)
OGD | CDER | FDA
Sunny Pyon
Labeling Project Manager
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
CDER | FDA
Vincent Sansone, PharmD
Captain (CAPT), United States Public Health Services (USPHS)
Director
Division of Project Management (DPM)
ORO | OGD | CDER | FDA
Rinku Patel, PharmD, BCPS, RAC
Commander, United States Public Health Service (USPHS)
Associate Director
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD | CDER | FDA
Tawni B. Schwemer
Senior Advisor
OGD | CDER | FDA
Learn more at: fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-gdf-2024-regulatory-considerations-enhance-generic-drug-access-04102024
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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
00:07 – Improving the Sterility Assurance Application to the FDA
17:57 – The Bacterial Endotoxins Specification - Points to Consider
36:16 – General Overview of ANDAs Labeling Requirements for Rx to OTC Switched Products
43:42 – Pending Applications
51:09 – Regulatory Reminders at the Finish Line
56:28 – Areas for Improvement
01:09:20 – Q&A Discussion Panel
01:23:33 – Closing Remarks
Speakers | Panelists:
John Arigo, PhD
Division Director
Division of Pharmaceutical Manufacturing Assessment (DPMA II)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER) | FDA
Erika Pfeiler, PhD
Unit Supervisor
Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI)
OPMA | OPQ | CDER | FDA
Bayli Larson, PharmD
Pharmacist
Patent and Exclusivity Team (PET)
Division of Legal & Regulatory Support (DLRS)
Office of Generic Drug Policy (OGDP)
OGD | CDER | FDA
Sunny Pyon
Labeling Project Manager
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
CDER | FDA
Vincent Sansone, PharmD
Captain (CAPT), United States Public Health Services (USPHS)
Director
Division of Project Management (DPM)
ORO | OGD | CDER | FDA
Rinku Patel, PharmD, BCPS, RAC
Commander, United States Public Health Service (USPHS)
Associate Director
Division of Legal and Regulatory Support (DLRS)
OGDP | OGD | CDER | FDA
Tawni B. Schwemer
Senior Advisor
OGD | 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
