FDA has published 57 product-specific guidances, including 35 new guidances and 22 revised guidances, describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs. Fifteen of the new draft guidances and four 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.
The FDA believes that increased transparency on product-specific recommendations gives manufacturers seeking to develop generic copies of complex drugs a better opportunity to efficiently allocate resources. The agency aims to make sure that policies and regulations – and scientific and clinical standards – keep pace with the evolving science around developing generic versions of these complex products so that patients have access to affordable medicines. Greater access to high quality generic drugs is key to giving us more ways 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
• Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs