Experts urge FDA to boost transparency of complete response letters and refine master protocol guidance

A recent paper in the Journal of Law and the Biosciences outlines ways the FDA could better disclose complete response letters to the public, aiming to increase transparency for stakeholders.

Industry and patient organizations have also asked the agency to modify its revised draft guidance on master protocols for drugs and biological products, seeking clearer rules.

Two industry groups are calling for the guidance to be more harmonized with international regulators, while a group representing clinical trial sites has raised concerns about the practicality of the recommendations at the site level.