Cell Based Assays, Drug Development and International

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”

Production

Production FDA Therapies Biochemical Assays

Drug Discovery Digest

Exploring alternatives to animal testing in drug discovery

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Webinars

Stay Connected