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www.fdanews.com/articles/131767-fda-should-follow-its-own-procedures-for-drugmakers-8217-postmarketing-promises-report

FDA Should Follow Its Own Procedures for Drugmakers’ Postmarketing Promises: Report

November 11, 2010
The FDA should better adhere to its manual of policies and procedures for tracking and communicating the status of postmarketing requirements (PMRs) and commitments (PMCs). Consulting firm Booz Allen, under contract with the FDA, examined the backlog of industry postmarketing studies and clinical trials for approved drugs and biologics as of September 2007. In its report, Booz Allen suggests the agency can better prioritize its review of certain PMRs and PMCs that can be closed out quickly.
Drug Industry Daily