FDA Law Blog

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. § 355(i)(1)(A). FDORA § 3209(a)(1).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

XTalks

MAY 22, 2023

It’s an extremely important factor I consider in my therapeutic process of restoring their natural beauty and appearance,” said Macrene Alexiades, MD, PhD, dual US-EU board-certified dermatologist, SkinVive by Juvéderm lead investigator and author of the clinical trial published in Dermatologic Surgery.

Filler 92

Filler FDA Approval Dermatology Production 92

FDA Law Blog

OCTOBER 11, 2022

We use the term “confirmatory evidence” as short-hand for one of the two ways explicitly defined in the Federal Food Drug & Cosmetic Act (“FD&C Act”) for demonstrating substantial evidence of effectiveness. Some may confuse this requirement for two studies as a need for replication.

Clinical Trials 61

Clinical Trials Clinical Trials Drugs Trials 61