USA – FDA Drafts Guidance on Tentatively Approved ANDAs

In a first for the US Food and Drug Administration (FDA) during the shutdown, the agency has posted new draft guidance to assist generic drug applicants in preparing and submitting amendments to tentatively approved abbreviated new drug applications (ANDAs), including requests for final approval.

“We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document,” the agency said. “This posting is to provide advance notice to the public. When publication in the FR becomes available, this document will be available in the FR as will a notice detailing how to submit comments on this document.”

The 12-page draft guidance provides recommendations on the timing and content of amendments to tentatively approved ANDAs to help companies reach final approval on the earliest date by which the ANDA may lawfully be approved.

In the background section, the draft walks readers through the process of submitting an ANDA, discussing paragraph I, II, III and IV certifications, and explains how and why FDA would tentatively approve an ANDA.

As far as amendments to tentatively approved ANDAs, the draft explains the review goals for amendments other than requests for final approval, and it also notes what will happen to ANDAs submitted and tentatively approved under the President’s Emergency Plan for AIDS Relief (PEPFAR)…