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FDA Hasn't Publicly Released A Device-Related Close-Out Letter For 5 Months, Defeating Purpose Of Program

 
• By Shawn M. Schmitt

Medical device manufacturers under the dark cloud of a US FDA warning letter work hard to close them out, and, importantly, receive a close-out letter from the agency that is posted online for everyone to see. Yet FDA hasn't publicly released such a missive to device companies since May – the longest gap since the close-out program began in 2010. FDA says it's aware of the problem.

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Where, oh where are the close-out letters?

Are you a regulatory wonk who scours US FDA's website for up-to-date warning letter close-outs? Well, good luck finding any.

The agency has not released a device-related close-out letter for more than five months – the first time it has...

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From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
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In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.

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