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Regulations & EHS&S



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


14/09/2018

The 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.

The 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 public health.

The 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 informatino and to view the guidances, visit::