Drug Industry Daily

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Clinical trial sponsors could have an easier time qualifying trial sites and training investigators as a new Big Pharma initiative aims to standardize these procedures and support mutual recognition of qualification and training.

Next month, the FDA will begin revealing its criteria for initial completeness tests for Type II active pharmaceutical ingredient (API) drug master files (DMF), an FDA official says.

Jazz Pharmaceuticals received an FDA warning letter for overstating the benefits and minimizing or omitting the risks of its schizophrenia drug FazaClo in a patient brochure.

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Thursday.

The House late Wednesday passed a fix that would allow the FDA to begin collecting the generic user fees authorized by the FDA Safety and Innovation Act (FDASIA).