Facilitating Generic Drug Product Development through Product-Specific Guidances

The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, revised, and published, and how PSGs may be used to improve the efficiency of generic drug development.
Timestamps
05:08 - PSG Program: Updates and Overview of Available Resources
30:03 - Beyond General Guidance: Tailored PSG Recommendations for Immediate Release Oral Drug Products
45:15 - Development of Generic Drug Products Under Suitability Petition
57:50 - Device and User Interface Assessment Recommendations in Drug-Device Combination Product PSGs
01:12:44 - Consideration Factors for Study Population Selection in Bioequivalence Studies with Pharmacokinetic Endpoints
01:28:00 - FDA Dissolution Methods and Navigating the Dissolution Database
01:38:14 - Panel Discussion
02:16:50 - Speaker Q&A Discussion Panel
02:56:03 - Closing Remarks
Speakers | Panelists:
Joseph Kotsybar, Pharm.D.
Regulatory Health Project Manager
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
CDER | FDA
Qi Zhang, Ph.D.
Lead Pharmacologist
Division of Therapeutic Performance II (DTP II)
ORS | OGD | CDER | FDA
Heather Boyce, Ph.D.
Lead Pharmacokineticist
DTP II | ORS | OGD | CDER | FDA
Karthika Natarajan, Ph.D.
Staff Fellow
DTP I | ORS | OGD | CDER | FDA
Jihong Shon, M.D., Ph.D.
Senior Staff Fellow
DTP II | ORS | OGD | CDER | FDA
Leah W. Falade, Ph.D.
Senior Pharmacologist
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Robert Lionberger, Ph.D.
Director
ORS | OGD | CDER | FDA
Dave Coppersmith, J.D.
Regulatory Counsel
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP)
OGD | CDER | FDA
Utpal Munshi, Ph.D.
Division Director
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
OGD | CDER | FDA
Markham Luke, M.D., Ph.D.
Division Director
DTP I | ORS | OGD | CDER | FDA
Myong-Jin Kim, Pharm. D.
Division Director
DTP II | ORS | OGD | CDER |FDA
Liang Zhao, Ph.D.
Division Director
Division of Quantitative Methods and Modeling (DQMM)
ORS | OGD | CDER | FDA
Lei Zhang, Ph.D.
Deputy Director
ORS | OGD | CDER | FDA
Learn more at: www.fda.gov/drugs/news-events...
-----------------------
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/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2022 Playlist - • 2022 CDER Small Busine...
SBIA LinkedIn -  / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cdersbialearn
Twitter -  / fda_drug_info
Email - [e-mail]
Phone - [phone] I [phone]