FDA Proposes Removal Of Duplicative Biologics Requirements In Regulations

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...