- The FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.
- The batch of 43 PSGs includes:
- 30 new and 13 revised PSGs
- 13 PSGs for complex products (11 new and 2 revised PSGs); 11 of these for products with no approved ANDAs (10 new and 1 revised PSGs)
- 34 PSGs for products with no approved ANDAs (23 non-complex and 11 complex products)
US FDA publishes product-specific guidances to facilitate generic drug development
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