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
https://www.fda.gov/media/109232/download
2. Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
https://www.fda.gov/media/160166/download
3. Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
https://www.fda.gov/media/163799/download
4. Statistical Approaches to Establishing Bioequivalence