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

FDA no longer has to require animal testing for new drugs. 2023 Jan 13;379(6628):127-128 2 Tan KW, et al. 2023 Jan-Dec;15(1):2220150. He also introduced new approaches to faster development and oversaw improvements in steps toward developing increasingly complex protein therapeutics and biosimilars.

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Drug Development Clinical Supply Production Protein Expression 64

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Bench Model Testing “Testing using model systems with representative materials, geometries, and/or other simulated use parameters to evaluate the implant and demonstrate SE.” We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

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FDA Animal Testing Engineering Regulations 44

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.

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FDA Animal Testing Pharmacokinetics Small Molecule 52