CDER Guidance Lays Out Process for Consolidating ANDAs
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application.
New guidelines lay out the Office of Generic Drugs process for consolidating ANDAs, a shift from earlier policies that “resulted in multiple ANDA numbers” and original filings for the same medicines. It follows several CDER updates, including one in August, targeting improved communications between the FDA and generic drugmakers.
Applications can now be grouped together under a parent version that should be linked to the dosage amount used in all bioequivalence studies and waivers.
The ANDA consolidation coordinator will handle primary ANDA decision-making, such as the initial request review and final determinations, the guidance says. The coordinator will check applications for: consolidation requests submitted for both parent and child ANDAs; accurate labeling; inclusion of all formulations and ANDAs; distribution and activity listings of generic ingredients; their quantity per dosage and weight to weight percentage; and proof of bioequivalent studies and waivers for the indicated strengths.
The agency has come under fire from generic drugmakers and politicians for the backlog of thousands of applications, hindering competition and turnaround. FDA responded with shorter GDUFA goal dates and updated policies focused on increasing communication within FDA disciplines and with applicants. This may be yielding results, as officials said earlier this month they are ahead of schedule in reducing backlog; of 5,707 applications received before Oct. 1, 2014, 3,810 are under review.
The four-page guidance, which went into effect last week, can be read here: fdanews.com/10-26-ANDAs.pdf.