Under the new GDUFA program, manufacturers support FDA targets

To reduce the growing backlog of approval applications from generics manufacturers, the FDA has recently introduced a five-year program called the GDUFA (Generic Drug User Fee Amendment). Under the new scheme, the FDA is authorized to collect fees from manufacturers for every drug submitted, and for each production facility involved. These fees will be used to fund the additional staff needed to process applications faster, and to revise inspection strategies. Overall, manufacturers can expect to pay around $299 million annually.

Specifically, the GDUFA program aims to reduce median approval times from 31 to 10 months, and to move from a pre-approval approach to a policy of continuous surveillance; this will involve installing risk-based inspection frequencies for facilities. The program also plans to ensure GMP compliance inspections parity between foreign and domestic sites, and to restrict entry of products from non-fee payers.

While the GDUFA chiefly concerns the FDA, it has clear implications for all global sites that wish to do business with the United States. And despite its impact on manufacturers' bottom line, the new program ultimately supports patient safety – a goal Merck supports at every opportunity.

For more information, visit www.fda.gov

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