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The FDA finalized its guidance for applicants on meeting regulatory requirements related to the content and formatting of the clinical pharmacology section of a proposed product label. Read More
The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Read More
As a precursor to the FDA’s official implementation of a quality metrics reporting program, the agency will begin accepting voluntary data submissions from drugmakers on the quality of their finished dosage form drugs and APIs in early 2018 for a pilot run of the risk-based system. Read More
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
The FDA issued a Form 483 to Baxalta after an inspection revealed a litany of observations including two from an earlier inspection that were not corrected. Read More