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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development

Development Production Immune Response Licensing

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

FDA Law Blog

JANUARY 23, 2023

Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act). This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol.

Trials

Trials Clinical Trials Clinical Trials Drugs

Clinical Research Informer

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans

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