Biotechnology Start-up Company - Clearing Logjam at FDA Allows Product Review to Resume

Challenge

Biotechnology start-up company was unable to obtain FDA’s drug review division’s acceptance of a clinical development proposal or recognition that the company could proceed to Phase 3. Such determinations were necessary for the company to assure its larger pharmaceutical business partner and investors that the agency agreed with its regulatory approach. The bureaucratic logjam and lack of clarity was costing the company valuable time and money, so it sought help from AGG.

Approach

AGG worked with FDA’s Center for Drug Evaluation and Research’s Office of Ombudsman to help facilitate a meeting with the review division and obtain more written formal guidance concerning the company’s clinical development plan. AGG, with co-counsel, also helped review and prepare for a Formal Dispute Resolution hearing proceeding, which escalated the matter beyond the review division for evaluation.

Result

The company obtained more formal guidance from the review division. In addition, as part of the Formal Dispute Resolution process, FDA agreed, in part, with the company’s clinical development program. With these guidances and confirmations, the company had more information and clarity to proceed.