FDA Commissions Study of its Drug, Biologics Application Processes

The U.S. Food and Drug Administration (FDA) released a new report that examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA, according to a medical industry e-mail news service. The report was commissioned to examine differences in applications approved by the agency during the first round of review (1st-cycle), compared to those applications that took multiple reviews (multi-cycle) before approval.

Reportedly, one of the most compelling findings was the positive impact "milestone meetings" held between a product sponsor and the FDA can have in making the drug review process more efficient by improving the quality of initial applications. The report, “Independent Evaluation of FDA's 1st Cycle Review Performance -- Retrospective Analysis,” showed the positive impact consulting with the FDA before beginning the final phase of human testing (end of Phase 2) can have on 1st-cycle approval rates.

Fifty-two percent of companies that held a meeting with the FDA at the end of Phase 2 trials received approval during the 1st review cycle, according to the report. In comparision, only 29% of sponsors that did not have consultation meetings in this phase gained approval during the 1st review cycle for their product. In addition, the report also noted a positive link between a 1st-cycle approval and an earlier consultation before the application is even submitted—of 58 products with these types of meetings, almost half received 1st cycle approval.

More and more companies reportedly are seeking early advice from the FDA. The independent report shows that increased communication with the FDA often results in a more informed and efficient drug development process, especially for products that represent a major innovation and have significant public health impact.

The independent study was conducted by Booz, Allen Hamilton in relation to the Prescription Drug User Fee Amendments of 2002 (PDUFA III). The assessment includes a detailed evaluation of the events that occurred during the review process of new molecular entities for new drug applications (NMEs for NDAs), and biological license applications (BLAs) submitted in FY 2002-04.

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