Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.
[fa icon="clock-o"] 1/30/13 8:13 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] gmp, final rule, FDA, medical device, Pharma, Biologics, Combination Products
Read More »Wrap-up of a few notable news stories from last week:
[fa icon="clock-o"] 1/21/13 7:57 AM [fa icon="user"] Ryan Kasun [fa icon="folder-open'] listing, MDD, EU, Medical Devices, us, gmp, mdufa III, FDA, FDASIA, enforcement actions, registration
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