Product-Specific Guidances for Generic Drug Development
To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.
Increased transparency on product-specific guidances gives applicants seeking to develop generic drugs a better opportunity to efficiently allocate resources. 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.
The agency routinely posts and revises product-specific guidances. FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances. The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.
In April 2019, the Product-Specific Guidances database was enhanced as follows:
- 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
- How to Submit Comments on a Product-Specific Guidance
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
- Drug-Related General Guidances: Main Page
- Bioequivalence Recommendations for Specific Products
- Dissolution Methods Database
- Withdrawn CDER Product Specific Guidances