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

FDA published 74 product-specific guidances (22 new guidances and 52 revised). 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. 

Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are no approved ANDAs. The majority of the revisions to these guidances provide recommendations on data standards formatting for clinical endpoint bioequivalence studies to align with Clinical Interchange Standards Consortium (CDISC) standards.

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.  

FDA always seeks feedback and considers all comments to the docket before finalizing product-specific guidances.

For more information and to view the guidances, visit:

• Product-Specific Guidances for Generic Drug Development
• FDA In Brief: FDA issues 74 product-specific guidances to promote generic drug access and drug price competition
• Federal Register Docket Number: 2019-03129