Product-Specific Guidances for Generic Drug Development

Product-Specific Guidances for Generic Drug Development

Today, the FDA published an enhanced version of the Product-Specific Guidances (PSGs) for Generic Drug Development web page. The enhancements add new functionality including text searching for active ingredient or Reference Listed Drug/Reference Standard RLD/RS product, filtering search results, easy-to-follow navigation, and more. This web page update is the latest in a series of FDA efforts to strengthen the agency’s online presence with the latest technologies. 

New features for the upcoming version of the PSGs page include:

• Text search of PSGs by active ingredient, or by the Reference Listed Drug (RLD) or Reference Standard (RS) application number
• Users can filter search results using a text search box
• Users can easily export search results in Excel, CSV, or PDF format
• Search results are now paginated, allowing for faster searching

The redesigned PSGs web page, along with last year’s Drug Shortages and Orange Book website updates, shows the agency’s commitment to developing effective means for the public to access important and useful information.The updated PSG web page can be found on the FDA website at: Product-Specific Guidances for Generic Drug Development.