USA – FDA Unveils 34 New and Revised Product-Specific Draft Guidances

The US Food and Drug Administration (FDA) on Wednesday released its latest batch of product-specific guidance documents to support the development of generic drugs, with 25 new and nine revised draft guidances.

HIV antiretrovirals and antibiotics topped the list of new draft guidances with a total of five, followed by drug products containing active ingredients to treat ophthalmic ailments and cancers. Among the revised product-specific drafts is one for azelaic acid and another for ivermectin—both of which were revised for the second time. The product-specific guidance is part of the agency’s push to spur generic competition…