The US FDA has issued a series of guidance’s to assists the sponsor and applicant in the generic drug development.
The May month has around 03 new/revised guidance under GDUFA and ICH provisions. The links of the guidance’s are provided below for quick review and reference.
FDA Updates:
1. Benefit-Risk Considerations for Product Quality Assessments
https://www.fda.gov/media/158204/download
2. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
https://www.fda.gov/media/158522/download
3. Risk Management Plans to Mitigate the Potential for Drug Shortages