By Nick Taylor
The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain. And it is a familiar scenario, with the FDA drawing heavily on the 2009 electronic drug registration and listing guidance.
By using existing processes, the FDA hopes to cut the burden on industry--and its own IT systems--as it tries to gather details of all facilities in the generic drug manufacturing supply chain. The agency expects the use of the file formats from the 2009 guidance to cut the time for each response to 2.5 hours.
The figure is based on the belief that most companies and facilities already know the electronic submission process and have their self-identification details readily available. The FDA will call for submission of the data in the coming weeks, after which manufacturers will have 60 days to gather and send the information.
With 3,000 responses expected, GDUFA gives the FDA a lot of data to organize. To make best use of the new information and help it meet requirements and deadlines, the agency plans to create two new databases. Again, the use of familiar file formats should lessen the burden on the FDA but it is still another potential IT headache at a time when its efforts face intense scrutiny.
In April, the Government Accountability Office (GAO) said the FDA IT modernization plans are "in jeopardy" and has consistently criticized the regulator over databases of drug production plants. GDUFA gives the FDA the chance to gather the well organized data it needs to end GAO attacks on the holes in its facility registration listings.
New draft guidance puts the data collection framework in place. The FDA expects manufacturers to submit Facility Establishment Identifiers (FEI), physical addresses, contact details and other information the GAO has said earlier databases lack. Gathering up-to-date, accurate data on the generic drug supply chain will go some way to equipping the FDA to tackle globalization challenges.
Manufacturers now have 60 days to comment on the draft guidance.
- see the Federal Register filing
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