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

FDA has published 54 product-specific guidances, including 42 new guidances and 12 revised guidances that, when finalized, 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. Twelve of the new draft guidances and six of the revised guidances are for complex drug products, including multiple products that don’t yet have generic competition. The agency will continue to routinely post and revise product-specific guidances.

FDA believes that 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 it begins work on the final versions of 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
• FDA In Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition