FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

SEPTEMBER 10, 2024

This approach also requires an early identification of molecular liabilities and rheological properties, generally using research-grade material supply, in conjunction with in-silico modelling to de-risk drug formulation. FDA no longer has to require animal testing for new drugs. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al.

Clinical Supply 64

Clinical Supply Drug Development Production Animal Testing 64

The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

FDA 52

FDA Animal Testing Pharmacokinetics Small Molecule 52