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The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.

The December month has around 04 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.

1. Controlled Correspondence Related to Generic Drug Development

    2. Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

    3. Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations

    4. Statistical Approaches to Establishing Bioequivalence

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