FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Eliminates 2 Pre-1972 Biologics Regulations

Feb. 19, 2016

The FDA is axing two regulations that define procedures for the agency’s review and classification of biological products licensed before July 1, 1972, deeming them obsolete.

The FDA says the regulations are unnecessary because more recent ones allow the agency to evaluate and monitor the safety and efficacy of biologics, according to a notice in the Federal Register.

Specifically, the final rule removes 21 C.F.R. §601.25 and 21 C.F.R. §601.26. Read the notice here: www.fdanews.com/02-11-16-RegulationsUpdate.pdf.