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

FDA published 36 product-specific guidances (26 new guidances and 10 revised) including 15 complex drug products and 29 products for which there are no approved ANDAs. 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.

Eight of the new draft guidances and seven of the revised guidances are for complex drug products, of which 13 were with no approved ANDAs. Three revisions to these guidances for complex products provide recommendations on data standards formatting for comparative 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
• Federal Register Notice: Product-Specific Guidances