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gmp, final rule, FDA, medical device, Pharma, Biologics, Combination Products

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the..


listing, MDD, EU, Medical Devices, us, gmp, mdufa III, FDA, FDASIA, enforcement actions, registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week: