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FDA Issues 54 New and Revised Product-Specific Guidances

Posted 13 September 2018 | By Michael Mezher 

FDA Issues 54 New and Revised Product-Specific Guidances

The US Food and Drug Administration (FDA) on Thursday issued a batch of 54 new and revised product-specific draft guidances detailing its expectations for companies looking to develop generic versions of those products.

Among the documents are 42 new and 12 revised guidances providing specific recommendations for the studies FDA believes are necessary to demonstrate that the products are therapeutically equivalent to their reference listed drug (RLD).

Many of the product-specific guidances are for recently approved drugs, including AbbVie’s Mavyret (glecaprevir and pibrentasvir), Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir), Novartis’ Rydapt (midostaurin), Celgene’s Idhifa (enasidenib) and Teva’s Austedo (deutetrabenazine), all of which were approved by the agency in 2017.

“With this new batch of guidance documents, we’re not only providing recommendations for some new generic drugs, but the FDA is also modernizing some of its previously-issued guidance to make sure they reflect the most efficient path for developing generics,” FDA Commissioner Scott Gottlieb said.

Of the 54 product-specific guidances, 18 (12 new and 6 revised) are for nonbiological complex drugs, 14 of which do not currently have any generic competitors.

“One of the key ways the FDA can increase patient access to high-quality generics is by providing guidance to encourage and foster development of these cost-saving medicines, especially when it comes to complex drugs that can be hard to copy,” said Gottlieb.

Developing generic versions of nonbiological complex drugs has proven challenging for industry in lieu of specific guidance from FDA, which prompted the Government Accountability Office (GAO) to call on FDA to publish plans to issue or revise guidance on complex generic drugs.

As the guidances are all in draft form, FDA is requesting comment from the public on the approaches described in the documents within 60 days to ensure the comments are considered before the agency moves to finalize the guidances.

FDA, Product Specific Guidances, Federal Register Notice

Categories: Regulatory News

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