Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

Development 161

Development Production Immune Response Licensing 161

XTalks

FEBRUARY 8, 2021

Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. This replaces the previous approval pathway for insulin drugs and their analogs which have historically been reviewed as new drug applications under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Production 78

Production Insulin Branding Generic Drugs 78

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

Trials 59

Trials Clinical Trials Clinical Trials Drugs 59