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).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

XTalks

MAY 22, 2023

The FDA granted approval based on promising clinical results, demonstrating that SkinVive enhances hydration, thereby improving skin smoothness of the cheeks and delivering a lasting radiant glow for up to six months with optimal treatment. “Skin quality is among the top concerns my patients express when seeking aesthetic treatments.

Filler 92

Filler FDA Approval Dermatology In-Vivo 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. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.

Clinical Trials 61

Clinical Trials Clinical Trials Drugs Trials 61