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FDA to develop GDUFA self-identification database; warns about ANDA backlog fee

By Gareth Macdonald , 27-Aug-2012
Last updated on 27-Aug-2012 at 14:32 GMT

The US FDA plans to establish a new database for manufacturing facilities required to ‘self-identify’ under new GDUFA laws.

The database – detailed in a new Q&A document - is for active pharmaceutical ingredient (API) and finished dosage manufacturers, packagers and bioequivalence and bioavailability (BE/BA) testing sites covered by GDUFA and is separate to the list of facilities required to register under the Federal Food, Drug and Cosmetic Act.

Agency spokesman Christopher Kelly told in-Pharmatechnologist.com that: “Under GDUFA, facilities are being required to self-identify, not register. FDA is establishing a new system for the electronic self-identification of generic industry facilities, sites, and organizations. 

Therefore, entities that are required to register and list (under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act) and those being required to self-identify under GDUFA will submit information separately to the respective systems.  Each system will populate its own database to meet unique requirements and deadlines.”

But, while the databases will be distinct – and may mean some firms need to submit data twice – the systems will employ the formatting and standards used by the existing Drug Registration and Listing System (eDRLS) and will be accessed via the FDA’s existing electronic submissions gateway.

In addition, the facilities, testing sites and organizations involved in ANDA submissions must provide Data Universal Numbering System (D-U-N-S) numbers and Facility Establishment Identifiers (FEI) to enable quick identification of each plant in the database.

Self-registration means additional time, but the FDA does not think the burden will be too great.

The agency estimates that preparing and submitting data will take just two and a half hours for each facility and – based on the 3,000 or so submissions it expects to receive – 7,500 hours across the whole industry. It also suggests that collecting this data will not involve additional cost for manufacturers.

ANDA backlog fees

In a separate notice in the Federal Register the FDA reminds generic drugmakers that it is not too late to withdraw pending abbreviated new drug applications (ANDAs) and avoid a backlog fee due to be applied on October 1.

To avoid the fee – a total charge of $50m that will be divided by the number of pending ANDAs – non-branded drugmakers are advised to withdraw their applications in writing no later than September 28. 

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