FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Discovery World

JANUARY 21, 2024

“Technology plays multiple roles in all stages of vaccine development,” says Kanekiyo. “It It is enabling computational protein design for vaccine immunogen discovery, and high-throughput and high-definition assays for quicker and more comprehensive characterisation of vaccine candidates and vaccine-elicited immunity.

Vaccine 130

Vaccine Computational Chemistry Animal Testing Engineering 130

Drug Discovery World

FEBRUARY 2, 2023

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden 1 – the Modernization Act 2.0. may not materially change the current drug approval process at the FDA.

Animal Testing 130

Animal Testing FDA Clinical Trials Drugs 130

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

FDA 40

FDA Science Small Molecule Immune Response 40