Guidance on FDA-hired Consultants for Biotechnology Protocols
05/07/2003
Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols dated May 2003. This draft guidance document is intended to explain when and how sponsors of clinical trials for certain products can request that FDA engage an independent consultant to participate in the review of protocols for clinical studies intended to serve as the primary basis of claims of efficacy. To download the guidance, click here. To view this notice, click here.
