Early meetings with FDA make drug review process more efficient

The US Food and Drug Administration has released a report that takes an in-depth look at the way the agency reviews applications for drugs and biologics that have not previously been approved by agency. The report was commissioned to look at differences in applications approved by the agency during the first round of review (first-cycle) compared to those applications that took multiple reviews (multi-cycle) before approval. 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, entitled Independent Evaluation of FDA's First Cycle Review Performance - Retrospective Analysis, showed the positive impact consulting with the agency before beginning the final phase of human testing (end of Phase II) can have on first-cycle approval rates. 52% of companies that held a meeting with the FDA at the end of Phase II trials received approval during the first review cycle. However, only 29% of sponsors that did not have consultation meetings in this phase gained approval during the first review cycle for their product. In addition, the report also noted a positive link between a first-cycle approval and an earlier consultation before the application is even submitted - of 58 products with these types of meetings, almost half received first cycle approval, an FDA statement noted.

"Unique aspect of FDA review"