Product-Specific Guidances for Generic Drug Development
Search Product-Specific Guidances for Generic Drug Development
FDA Product Specific Guidance Snapshot (PDF - 150 KB)
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 Generic Drug Product Development web page.
The Product-Specific Guidances database features:
- Text search of PSGs by active ingredient or by the Reference Listed Drug (RLD) or Reference Standard (RS) application number
- Filtered search results using a text search box
- Option to export search results in Excel, CSV, or PDF format
- Paginated search results, allowing for faster searching
New in Generic Drug User Fee Amendments (GDUFA) III:
When a new or revised PSG is published and an applicant or prospective applicant has already commenced an in vivo bioequivalence study (i.e., the study protocol has been signed by the study sponsor and/or the contract research organization), the applicant or prospective applicant may request a PSG Teleconference to obtain agency feedback on the potential impact of the new or revised PSG on its development program. Pre-submission or post-submission PSG meetings may be requested following feedback received at the PSG teleconference. Refer to the GDUFA III Enhancements to the Pre-ANDA Program web page for additional details.
- GDUFA III Enhancements for the Pre-ANDA Program
- FDA Product Specific Guidance Snapshot (PDF - 150 KB)
- FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs (pre-recorded webinar)
- How to Submit Comments on a Product-Specific Guidance
- Upcoming Product-Specific Guidances for Generic Drug Product Development
- Drug-Related General Guidances
- Bioequivalence Recommendations for Specific Products Final Guidance (June 2010) (PDF - 80 KB)
- Dissolution Methods Database
- Withdrawn CDER Product Specific Guidances (PDF - 90 KB)