FDA's ANDA Approvals
Generic drug approvals and tentative approvals in late October and early November.
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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.