In the August 22, 2014, Federal Register, FDA proposed an amendment to the biologics regulations that would remove the general safety test ("GST") requirements for biological products. The proposed changes respond to a January 18, 2011, Executive Order mandating a retrospective review of agency regulations and guidance documents to improve regulation and remove unnecessary obstacles to innovation. According to FDA, existing, codified GST regulations are duplicative of requirements also specified for biologics licenses, or are no longer needed to help ensure the safety, purity, and potency of licensed biologics. Specifically, the proposed change would remove the requirements contained in 21 C.F.R. §§ 610.11, 610.11a, and 680.3(b) from the regulations. Comments due November 20, 2014.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.