FDA seeks input on product-specific guidances to facilitate generic drug development - Drug Information Update

FDA seeks input on product-specific guidances to facilitate generic drug development

FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including 16 PSGs for complex drug products.  Five of the new draft guidances and 11 of the revised draft guidances are for complex drug products.  Nearly half of these 53 PSGs (8 complex and 18 non-complex) are for products with no approved Abbreviated New Drug Application (ANDA). 

The agency aims to ensure that policies and regulations – and scientific standards – keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports FDA’s mission to advance the public health.  

FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page which provides information about FDA’s plans for issuing new or revised PSGs in the coming year for complex products as defined in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Commitment Letter. This page is updated each time FDA issues a new quarterly PSG batch. Each update removes the published PSGs and adds additional PSGs under development or revision. 

When finalized, these guidances will describe the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs.  FDA considers all comments to the docket before finalizing PSGs. 

For more information, to view the guidances, or to submit comments on the PSGs, visit:

• Product-Specific Guidances for Generic Drug Development
• Federal Register Notice: Product-Specific Guidances
• Upcoming Product-Specific Guidances for Complex Generic Drug Product Development