CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI): Generic Drugs Forum April 11 -12, 2018
Presentations
- Keynote Address by Dr. Uhl (1of27) Generic Drugs Forum 2018
- Pharmaceutical Quality Update by Dr. Michael Kopcha (2of27) Generic Drugs Forum April 2018
- ANDA Performance/Operations Update (3of27) Generic Drugs Forum April 2018
- Office of Pharmaceutical Quality (OPQ) Policy Update (4of27) Generic Drugs Forum April 2018
- Good ANDA Submission and Assessment Practices and Software Support (5of27) Generic Drugs Forum 2018
- Challenges in Generic Drug Safety and Surveillance (6of27) Generic Drugs Forum 2018
- Electronic Submissions (7of27) Generic Drugs Forum 2018
- Using the ePortal to Submit a pre-ANDA Meeting (8of27) Generic Drugs Forum 2018
- Panel Discussion (9of27) Generic Drugs Forum 2018
- GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018
- Orange Book: 101 An Overview (11of27) Generic Drugs Forum 2018
- Determining Whether to Submit an ANDA or a 505(b)(2) Application (12of27) Generic Drugs Forum 2018
- Panel Discussion (13of27) Generic Drugs Forum 2018
- GDUFA II – Review Timelines (14of27) Generic Drugs Forum 2018
- Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15of27) Generic Drugs Forum 2018
- Best Practices for Conducting Bioequivalence Studies (16of27) Generic Drugs Forum 2018
- Bioequivalence Site and Manufacturing Facility Information in Applications (17of27) GDF 2018
- Microbiology Quality Assessment (18of27) Generic Drugs Forum 2018
- Integrated Quality Assessment Process (19of27) Generic Drugs Forum 2018
- Panel Discussion (20of27) Generic Drugs Forum 2018
- GDUFA II User Fees: Update on Year One (21of27) Generic Drugs Forum 2018
- Generic Drug Product Quality Assessment (22of27) Generic Drugs Forum 2018
- Drug Substance Quality Assessment: Best Practices (23of27) Generic Drugs Forum 2018
- Application Communications: RBPM Communication with Industry throughout the IQA (24of27) GDF 2018
- Laboratory Science to Support Risk-Based Quality Assessments (25of27) Generic Drugs Forum 2018
- Integrated Process and Facilities Assessment (26of27) Generic Drugs Forum 2018
- Panel Discussion (27of27) Generic Drugs Forum April 11-12, 2018
You are invited to this two-day FDA led Regulatory Education for Industry (REdI): Generic Drugs Forum 2018. Join over 1000 participants from across the globe as we gather together in this opportunity to interact with FDA subject matter experts involved in the Generic Drug Review Program. You will obtain up-to-date information on program progress and current initiatives.