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 – Office of Generic Drugs Keynote: Collaboration and Tools for Success
16:32 – Key Components to Assure Pharmaceutical Quality
37:26 – FDA’s Role in Preventing and Mitigating Drug Shortages
Speakers:
Iilun Murphy, MD
Director
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER) | FDA
Susan Rosencrance, PhD
Acting Deputy Director of Science
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Jouhayna Saliba, PharmD
CAPT, United States Public Health Service (USPHS)
Team Leader
Drug Shortages Staff (DSS)
Office of the Center Director (OCD)
CDER | FDA
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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 - https://www.fda.gov/cdersbia
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