CDER creating medical policy board
FDA is creating a medical policy board at the Center for Drug Evaluation and Research to enhance the consistency of medical policies, CDER Director Janet Woodcock told BioCentury. Woodcock, who announced the initiative to CDER staff on Friday, said the new board is a response to complaints from drug sponsors that review divisions often take different, sometimes contradictory, approaches to similar issues.
Examples of issues the board will work on include creating a CDER-wide policy for obtaining approval based on a single trial, and the types of evidence that can be used to supplement a single trial. The board also will establish standards for use of the Animal Rule to obtain approvals of bioterrorism countermeasures based on efficacy studies in animals, Woodcock said.
In addition to consistency, the new body will also examine whether approval standards are infeasible, and if they are, establish new standards. The board's conclusions will be published and will be subject to public comment procedures, Woodcock said. It will be headed by Rachel Sherman, director of CDER's Office of Medical Policy