South African medicines agency tackles backlog
This article was originally published in SRA
The South African Medicines Control Council has extended until the end of October an initiative aimed at tackling the backlog of applications that has built up over the past few years. The project began on 1 July and had been scheduled to finish on 30 September.
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.