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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 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

2. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

3. Risk Management Plans to Mitigate the Potential for Drug Shortages

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