Friday, 7 November 2014

FDA – general safety testing


Revocation of general safety test regulations that are duplicative of requirements in biological license applications.

Here,  FDA is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.

See: FDA

Posted by Tim Sandle