The FDA and BIO agree that pending legislation would expand the scope of the accelerated drug approval program, but FDA Center for Drug Evaluation and Research Director Janet Woodcock says the results may not be immediate. "The real problem is the paucity of worked-up endpoints, either as surrogates or as clinical endpoints that could be used for accelerated approval," she said. Alnylam Pharmaceuticals CEO John Maraganore said progress is needed "when it comes to FDA accepting clinical endpoints" and that Congress can help by making it clear that it wants greater use of the accelerated approval process.

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