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A new draft guidance document issued by the US Food and Drug Administration (FDA) calls for all over-the-counter (OTC) drugs containing acetaminophen to be labeled with a new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 …
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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 …
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FDA to Lift Ban on Blood Donations by Gay Men
TUESDAY, Dec. 23, 2014 (HealthDay News) — Gay and bisexual men who have abstained from sex for one year will be allowed to donate blood in the United States, under a new federal policy that would reverse a 31-year ban on donations from men who …
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FDA Warns Against Fetal 'Keepsake' Videos
The FDA also has concerns about over-the-counter sales and use of Doppler ultrasound heartbeat monitors, which are used to listen to the heartbeat of a fetus. These devices should only be used by, or under the supervision of, a health professional.
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FDA Staff Gets Support for New Antiseptic Standards, but…
Meeting September 3, the FDA's Nonprescription Drugs Advisory Committee voted unanimously (12 to 0) to recommend that the staff members go ahead and propose new safety standards for 11 common over-the-counter healthcare antiseptic ingredients.
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FDA Announces Major Agency Reorganization, With Focus on Drug Quality
OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA. Accordingly, Woodcock announced that the Office of Pharmaceutical Science (OPS), Office …
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Certain Meds, Driving Can Be Deadly Mix: FDA
"You can feel the effects some over-the-counter medicines can have on your driving for a short time after you take them, or their effects can last for several hours," Dr. Ali Mohamadi, a medical officer at the FDA, said in an agency news release. "In …
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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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