Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 3-Session 2



Published
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

01:39 – Introduction to Bioequivalence for Generic Drug Products

31:58 – Bioequivalence Studies for Generic Drug Development

1:05:26 – Essential Elements of Biopharmaceutics Classification System (BCS III)-Based Waiver Request

1:40:28 – BCS Methodology: Solubility, Permeability & Dissolution

1:53:02 – Biowaiver Aspects from a Biopharmaceutics Perspective: Our role in A/NDA original and post-approval Applications

2:12:13 – Question & Answer Panel

2:33:44 – Closing Remarks

Speakers:

Ja Hye Myung, PhD, MS, BPharm
Pharmacologist
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD) | CDER | FDA

Rong Wang, PharmD, PhD
Acting Division Associate Director
Division of Bioequivalence I (DBI)
OB | OGD | CDER | FDA

Yi Zhang, PhD
Commander, USPHS
Senior Advisor
Division of Therapeutic Performance II (DTPII)
Office of Research and Standards (ORS)
OGD | CDER | FDA

Donna A. Volpe, PhD
Research Chemist
Division of Applied Regulatory Science
Office of Clinical Pharmacology (OCP)
CDER | FDA

Haritha Mandula, PhD
Senior Pharmaceutical Quality Assessor
Division of Biopharmaceutics
OND | CDER | 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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Category
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