New CBER tracking system
This article was originally published in Pharmaceutical Approvals Monthly
The Center for Biologics Evaluation and Research implemented a new tracking system in July for approved biologics and submissions as part of its database redesign. BLA reference numbers have been replaced by Submission Tracking Numbers (STNs). "A list of STNs for approved products will be made available on CBER's website at a later date," according to CBER. The center is also in the process of redesigning its website to make it more user-friendly. The redesigned website will debut in the next few week
You may also be interested in...
A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.
Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.