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Pharmaceuticals / Regulatory Affairs

FDA Offers Advice for Topical OTCs

May 20, 2019

The FDA is willing to hold private meetings with sponsors of over-the-counter creams, gels and other topical medicines to protect trade secrets—but sponsors should understand that the meetings will eventually see the light of day, the agency says.

In a final guidance on  maximal use trials to support over-the-counter monographs for topical treatments, the agency says it is sensitive to sponsors’ “concern about making certain information about the development of their [maximal use trial] programs public prematurely, while they are still considering whether and how to begin such testing” so regulators are willing to keep pre-trial meetings on the downlow for at least a little while.

The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets.

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