FDA presents on the Current State of Generic Drugs and offers practical advice, presenting case studies, and taking a deep dive into the abbreviated new drug application assessment program. Presentations focus on topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs. Includes Q&A session and a moderated panel discussion.
0:03 – Best Practices and Strategies for Communication with FDA
23:57 – Division of Filing Review: Best Practices for ANDA and Controlled Correspondence Submissions
41:22 – Question & Panel Discussion
57:14 – Project Management of Premarket and Postmarket Generic Drug Safety
1:15:25 – Best Practices for Conducting Comparative Analyses in ANDAs
1:36:04 – Questions & Panel Discussion
Presenters and Panel:
Robert Gaines
Deputy Director, Office of Program and Regulatory Operations (OPRO), Office of Pharmaceutical Quality (OPQ) | CDER
Warren Simmons
Lieutenant, USPHS
Regulatory Project Manager – Office of Regulatory Policy (ORP) | Office of Generic Drugs (OGD) | CDER
Peter Enos
Filing Reviewer, Division of Filing Review (DFR), Office of Regulatory Operations (ORO) | OGD | CDER
Elizabeth Kim, LCDR, USPHS
Controls Coordinator, DFR, ORO | OGD | CDER
Julia Lee
Deputy Director, DFR | ORO | OGD | CDER
Tu-Van Lambert
Senior Regulatory Health Project Manager, Division of Clinical Safety and Surveillance, OSCE | OGD | CDER
Andrew Fine, CDR, USPHS
Senior Advisor, Division of Clinical Review (DCR), Office of Safety and Clinical Evaluation (OSCE) | OGD | CDER
For slides and additional information: [ Ссылка ]
--------------------
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 - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2022 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367
