FDA Unveils 34 New and Revised Product-Specific Draft Guidances

Regulatory NewsRegulatory News | 15 May 2019 |  By 

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.

Gilead received FDA approval for one out of the three HIV antiretrovirals—Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide)—as recently as last February. Bristol-Myers Squibb’s HIV medicine Sustiva (efavirenz) and GlaxoSmithKline’s hepatitis B and HIV drug Epivir (lamivudine) were approved in 1998 and 2001, respectively.

Each guidance provides product-specific recommendations to aid manufacturers in the design of bioequivalence studies in support of abbreviated new drug applications. With each new batch of guidance, the total number of product-specific guidances reached 1,744 since 2007.

The last set of product-specific guidance was issued in February, including 22 new and 52 revised draft guidances.



© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy