FDA Slowly Chips Away at ANDA Backlog

Posted 02 May 2016 By Zachary Brennan

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Although the total workload of abbreviated new drug applications (ANDAs) continues to rise, the number of ANDAs currently with the US Food and Drug Administration (FDA) has declined by about 160 ANDAs over the past three months, according the agency’s second generic drug review dashboard released on Monday.

The latest data, covering the period from January through March 2016, shows that the number of ANDAs pending filing review has declined from 211 ANDAs as of 1 January to 160 ANDAs as of 1 April. Increasingly, FDA is waiting to hear from industry on a higher number of ANDAs as the total number of ANDAs awaiting industry action has increased from 1,143 to 1,332 in the latest data.

All told, the current ANDA workload (combination of ANDAs awaiting industry response – 1,143 – and the number of ANDAs with FDA – 2,962) has increased since the release of the first data dashboard by 29 applications.

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But FDA’s fervent pace of approving ANDAs from last year is slowing. From January through March, FDA approved or tentatively approved a total of 198 ANDAs, which was 40 less ANDAs approved or tentatively approved from the previous three-month stretch. However, the number of ANDAs with “easily correctible deficiency/information” (ECD/IRs) requests spiked to 632 ANDAs in March, which was the highest number since June 2015.

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“The increase in ECD/IRs issued demonstrates the Agency’s commitment to increasing communications with industry,” FDA said.

The release of the May dashboard comes as negotiations for the next iteration of the Generic Drug User Fee Act (GDUFA) continues and as  Janet Woodcock, director of the Center for Drug Evaluation and Research, told senators in January that the agency expects to be fully caught up with the ANDA backlog before the re-authorization of GDUFA in 2017.

The Generic Pharmaceutical Association (GPhA), an industry group representing the interests of generic drug companies, has taken issue in recent months with FDA’s transparency efforts and its progress with the ANDA backlog.

Generic Drug Review Dashboard May 2016

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Categories: Generic drugs, Compliance, Due Diligence, Government affairs, Submission and registration, News, US, CDER

Tags: ANDA backlog, generic drug applications, FDA generic approvals

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