After Intense Scrutiny, FDA Set to Take Another Look at OTC Antiseptics
In a 28 July 2014 notice posted by FDA in the Federal Register, the regulator said it was calling a meeting of its Nonprescription Drugs Advisory Committee (NDAC) in September 2014, which will discuss the safety and efficacy of various antiseptic products.
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FDA Rules Differ for OTC vs. POC Glucose Monitors
The FDA released two draft guidances that establish a line between over-the-counter and point-of-care blood glucose monitors. In the past, the agency didn't distinguish between consumer and professional uses of blood glucose monitors, but now they want …
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FDA holds hearing on OTC drug review process; accepting comments until May 12
According to FDA's Federal Register Notice, FDA seeks comments on the strengths and weaknesses of the existing OTC review process, modernization concepts, and modification of or alternatives to the existing OTC review process. FDA apparently believes …
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