THIRD-PARTY REVIEWS COULD HURT "PROFESSIONALISM" OF FDA, KESSLER TELLS HOUSE HEARING; FDA SHOULD NEGOTIATE AND PAY FOR THIRD-PARTY CONTRACTS -- PhRMA
Third-party drug reviews suffer from a "lack of continuity," FDA Commissioner Kessler told the House Commerce/Health Subcommittee hearing on FDA reform legislation May 1. "FDA's reviewers are able to work with the same drug over time," Kessler testified, "first reviewing the IND, then reviewing the NDA." Continual involvement in a drug's development, he maintained, allows reviewers to build on what they already know about the drug.
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