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COVID-19 Impact on Generic Drug Regulation and Evaluation

FDA discusses the challenges and agency solutions to unique problems posed to generic drug regulation and evaluation during the COVID-19 Public Health Emergency. Includes responses to audience in a question-and-answer panel. Presenters and presentations include: Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Mitchell Frost, MD; ORS|OGD|CDER Alternative Bioequivalence Approaches for Data Analysis Due to COVID-19 Related Study Interruptions Yuqing Gong, PhD; DQMM|ORS|OGD|CDER Quality Considerations in the Development of FDA Guidance “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency” Gloria Huang, PhD; OPQ|CDER Applications and Lessons Learned for Conducting Adaptive Designs on Generic Drug Development Kairui (Kevin) Feng, PhD; DQMM|ORS|OGD|CDER Q&A Panel (Including all above presenters): Kimberly Witzman, MD; DCR|OSCE|OGD|CDER Stella C. Grosser, PhD; Division of Biometrics VIII|OB|OTS|CDER For slides and additional information: https://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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367