In late May, FDA released a final guidance for industry on expedited programs for serious conditions, which reflects comments that came in on the draft released in June 2013 (See IPQ Sept. 16, 2013 and Sept. 26, 2013). The guidance acts as a single resource for policies and procedures related to the four FDA programs designed to expedite approval: ● fast track ● breakthrough therapy ● accelerated approval, and ● priority review. The guidance contains definitions of the concepts surrounding expedited approval, as well as the qualifying criteria and features of each of the different programs. Also included are general considerations and appendices discussing the processes of the programs. [An analysis of the changes to the final version of the guideline will be included in IPQ’s upcoming coverage of the evolving dialogue on the CMC implications for the breakthrough therapy pathway.]
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