In the August 8, 2016, Federal Register, FDA announced it is reopening the comment period for the potential development of a user-fee program for nonprescription, or OTC, monograph drugs. FDA initially requested comments and announced a public meeting in the May 11, 2016, Federal Register. The public meeting was held on June 10, 2016, and meeting materials, including a transcript, are available here. FDA recently held a webinar (on September 6, 2016) as a follow-up to the June 2016 public meeting and to provide updates on FDA-industry discussions that began in July 2016 (meeting minutes for those discussions can be found here). Additional information is available here. Comments are due October 6, 2016.

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