SUMMARY DATA-BASED NDAs "WILL SERIOUSLY COMPROMISE" DRUG REVIEW PROCESS, COM. KESSLER SAYS; FDA "STRONGLY OPPOSES" PROVISION ALLOWING ONE PIVOTAL TRIAL
Executive Summary
The PhRMA-supported proposal to allow NDAs based on summary data would "seriously compromise FDA's review process," FDA Commissioner Kessler asserted May 1 at the House Commerce/Health Subcommittee hearing on FDA reform.