U.S. Food and Drug Administration | Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access-Day 1, Pt 3 @US_FDA | Uploaded 2 months ago | Updated 8 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
00:09 – Overview of Controlled Correspondence: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondence Received by the Office of Bioequivalence
12:27 – Overview of Controlled Correspondence Part II: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondence Received by the Office of Bioequivalence
21:39 – Overview of Quality-Related Controlled Correspondence (CC)
38:01 – Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III
57:08 – Unveiling the Data: Post-Complete Response Letter Scientific Meeting Requests under GDUFA III
01:17:42 – Q&A Discussion Panel
Speakers | Panelists:
Marcia Fields
Lieutenant Commander (LCDR), United States Public Health Service (USPHS)
Regulatory Officer
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evalutation and Research (CDER) | FDA
Zhen Zhang, PhD
Master Pharmacologist
Division of Bioequivalence I (DB I)
Office of Bioequivalence (OB)
OGD | CDER | FDA
Jenn Anim
Pharmacologist - Policy Lead
Division of Internal Policy and Programs (DIPP)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality OPQ
CDER | FDA
Maria Monroy-Osorio
Regulatory Health Project Manager
Office of Research and Standards (ORS)
OGD | CDER | FDA
Hiren Patel, PhD
Senior Staff Fellow
Division of Bioequivalence II (DB II)
Office of Bioequivalence (OB)
OGD | CDER | FDA
Karen Bengtson
Supervisory Regulatory Health Project Manager
Office of /research and Standards (ORS)
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
00:09 – Overview of Controlled Correspondence: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondence Received by the Office of Bioequivalence
12:27 – Overview of Controlled Correspondence Part II: GDUFA III Updates and a Comprehensive Analysis of Controlled Correspondence Received by the Office of Bioequivalence
21:39 – Overview of Quality-Related Controlled Correspondence (CC)
38:01 – Overview and Considerations of Pre-ANDA Scientific Meetings Under GDUFA III
57:08 – Unveiling the Data: Post-Complete Response Letter Scientific Meeting Requests under GDUFA III
01:17:42 – Q&A Discussion Panel
Speakers | Panelists:
Marcia Fields
Lieutenant Commander (LCDR), United States Public Health Service (USPHS)
Regulatory Officer
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evalutation and Research (CDER) | FDA
Zhen Zhang, PhD
Master Pharmacologist
Division of Bioequivalence I (DB I)
Office of Bioequivalence (OB)
OGD | CDER | FDA
Jenn Anim
Pharmacologist - Policy Lead
Division of Internal Policy and Programs (DIPP)
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality OPQ
CDER | FDA
Maria Monroy-Osorio
Regulatory Health Project Manager
Office of Research and Standards (ORS)
OGD | CDER | FDA
Hiren Patel, PhD
Senior Staff Fellow
Division of Bioequivalence II (DB II)
Office of Bioequivalence (OB)
OGD | CDER | FDA
Karen Bengtson
Supervisory Regulatory Health Project Manager
Office of /research and Standards (ORS)
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
