FDA Drafts 26 New Product Specific Guidances for Generic Drugmakers
The batch of new and revised US Food and Drug Administration (FDA) guidance features 43 product-specific guidances, including 26 new guidances and 17 revised guidances that, when finalized, will describe FDA’s expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs.Ten of the new draft guidance documents and six of the revised guidances are for complex drug products: an area that’s been a focus for FDA as these products can be more difficult for manufacturers to develop.
The new guidance also includes multiple products that do not yet have generic competition, as well as three revised product-specific guidances for abuse-deterrent formulations of opioid analgesics.
The new guidances include ones for ciprofloxacin, epinephrine, omeprazole and rifapentine. And the revised guidances include ones for lansoprazole, latanoprost and ticagrelor.
FDA Commissioner Scott Gottlieb said in a statement: “The documents issuing today add to the nearly 1,600 product-specific guidances we’ve published to date across therapeutic classes, ensuring our policies and standards keep pace with the evolving science of equivalence for generics, enabling greater patient access to high-quality, affordable medicines.”
Product-Specific Guidances for Generic Drug Development