FDA posts lists of product-specific guidances under development or revision to provide increased transparency and support complex generic drug product development and approval

The U.S. Food and Drug Administration (FDA) today launched a new web page, Upcoming Product-Specific Guidances for Complex Drug Product Development.

In January 2018, the U.S. Government Accountability Office (GAO) publicly released a report entitled “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs.” In preparing the report, GAO studied a number of issues related to the FDA’s assessment and approval of complex drug products. The report contained a single recommendation for the FDA – that the agency publicly announce its plans to issue or revise guidance for these drug products.

This new web page provides information about FDA’s plans for issuing new or revised product-specific guidances (PSGs) in the coming year for complex products as defined in the Generic Drug User Fee Amendments Reauthorization (GDUFA II) Commitment Letter.  The web page will be updated each time FDA issues a new quarterly PSG batch.  Each update removes the posted PSGs and adds additional PSGs under development or revision.  The information on this web page is anticipated to help generic drug companies better plan their development of complex generic drug products.

For more information on PSGs and the new web page, please visit: Product-Specific Guidances for Generic Drug Development.