R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Final Rule - Combination Products

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.

Quick Hits - December 11, 2012

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:

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