CDER SBIA hosted a three, half-day conference in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program. Which is intended to help National Medicines Regulatory Authority's (NMRA) in low-and middle-income countries (LMICs) gain a better understanding of FDA's role in international regulatory harmonization, and regulatory resources available to NMRAs in LMICs. Presentations covered topics such as FDA drug approval pathways and FDA review of drug applications (new and generic drugs) with specific emphasis on approval pathways for new TB medicines, and USP and USAID’s PQM+ capabilities for strengthening regulatory systems in LMIC.
Timestamps
00:58 - Bringing New TB Drugs to Market: A Regulatory Perspective
31:09 - FDA’s Use of the Tentative Approval Pathway to Meet the Urgent Needs of PEPFAR
1:28:46 - Project Facilitate: An Overview of Expanded Access and the Review Process
2:01:49 - Questions & Answer Panel
Speakers:
Ramya Gopinath, MD
Medical Officer
Division of Anti-Infectives (DAI)
OND | CDER
Tina T. Nhu, PharmD, Mc. PM
Commander (CDR), USPHS
Team Leader, Regulatory Project Manager
Division of Project Management (DPM)
Office of Generic Drugs (OGD) | CDER
Peter Capella, PhD
Director
Division of Immediate and Modified Release Products II (DIMRPII)
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ) | CDER
Monica Zeballos, PharmD, RPh
Captain (CAPT), USPHS
Senior Program Consultant
Division of Antivirals (DAV)
Office of Infectious Diseases (OID) OND | CDER
Mitchell Chan, PharmD, BCPS
Lieutenant Commander, USPHS
Clinical Analyst
Team Leader, Project Facilitate
Oncology Center of Excellence (OCE) | FDA
Panelists:
Same as above
Learn more at: Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines - 08/16/2022 | FDA
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31 авг 2022
