FDA seeking input for CDER's Medical Policy Council

FDA is seeking input from outside stakeholders on potential policy issues to be considered by the Medical Policy Council, which the agency's Center for Drug Evaluation and Research (CDER) created in January 2012 to provide a senior-level forum to discuss and implement medical policies. CDER said the council also will aim to help coordinate medical policy development and implementation within the center and to communicate medical policy decisions to the public (see BioCentury, Jan. 6, 2012).

According to FDA's notice, the council typically will consider policy issues that require input from senior management at FDA or are issues on which CDER has taken inconsistent positions. The council also will take up issues triggered by a specific product that would apply to other products, or an existing policy that should be reconsidered due to scientific or regulatory advances. Comments are due July 16. FDA could not be reached for comments on how often the council will meet and whether the meetings will be made public. ...