By Harley Everett Wilcox, MBA
Recent FDA public hearings in 2012 and 2014 regarding
non-prescription drugs suggest the agency is interested in modernizing the over-the-counter drug process. The 2012 docket discusses topics on providing
citizens with more options for obtaining prescription drugs including relying
on self-diagnosis, new technology, and pharmacies vs. standard physician visits.
The 2014 docket outlines current issues with the OTC monograph system and requests
public comments for improvements. There is yet an outcome of these meetings and
suggested changes to the OTC process and regulations. A more in-depth examination of the current
processes, weaknesses, and possible changes will be addressed in a future
presentation. The discussion will cover the monograph system, types of
submissions, and possible OTC changes that may include new guidelines or
updates to current procedures such as the NDA Deviation.
Let me know what you think about the dockets and possible outcomes in the comment section below.
Let me know what you think about the dockets and possible outcomes in the comment section below.
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