FDA Law Blog

FEBRUARY 2, 2023

The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Clinical Trials 64

Clinical Trials Clinical Trials In-Vivo In-Vitro 64

XTalks

MAY 22, 2023

Research conducted by Allergan Aesthetics using ex vivo human skin samples and an in-situ study on the volar forearms of healthy volunteers demonstrated that hyaluronic acid (the primary active ingredient in SkinVive) can enhance collagen density in the upper reticular dermis and increase fibrillin-1 expression.

Filler 92

Filler FDA Approval Dermatology Production 92

Roots Analysis

AUGUST 8, 2023

Introduction to Liposome Liposome was initially identified and described as swollen phospholipid systems, called Banghasomes, by British hematologist Alec D. Bangham, in 1961 at the Babraham Institute, University of Cambridge. The various therapeutic applications of liposomes in drug delivery have been highlighted in the figure.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Drugs In-Vivo 52

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