Bioequivalency, Containment, Cosmetics and Development

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Bioequivalency

Containment

Cosmetics

Development

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. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

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

More recently, in April 2022, the agency issued draft guidance recommending sponsors to develop Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

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

Stay Connected