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Focus on Regulation

Major FDA Announcement on OTCs

After years of rumbling, the U.S. Food and Drug Administration (FDA) has taken initial steps to examine whether and how to modernize the over-the-counter (OTC) drug review processes and regulatory framework.   FDA is exploring ways to re-engineer the OTC monograph system to, among other things, create a process that is more efficient and more responsive to newly emerging information and evolving science, and to allow for more rapid product innovation where appropriate.

As a first step, FDA has announced a March 25 and 26, 2014 public hearing to gather information and comments on the strengths and weaknesses of the current OTC monograph process, and to discuss ideas about modifications or alternatives.  Following the meeting, FDA will accept written or electronic comments for consideration until May 12, 2014.

The notice of public hearing; request for comments is available here