FDA Orders New Warnings on OTC Acetaminophen Drugs
A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new statement warning consumers about the risk of the products causing serious …
Read more on Regulatory Focus
iGrow Hair Growth System Receives FDA Over-the-Counter Clearance for Women
BOCA RATON, Fla.–(BUSINESS WIRE)–Apira Science, Inc. today announced the FDA has granted the company over-the-counter (OTC) clearance for its iGrow® Hair Growth System to effectively promote hair growth in women with Fitzpatrick skin phototypes …
Read more on Business Wire (press release)
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.
Read more on Regulatory Focus
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 …
Read more on MedPage Today
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 …
Read more on Lexology (registration)