Posts tagged ‘FDA’

January 3, 2015

Certain Meds, Driving Can Be Deadly Mix: FDA

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 …
Read more on WebMD

Over-the-counter contraception not on Republican agenda
A number of Republican candidates surmounted Democrats' “war on women” attacks in this year's campaigns by calling for birth control to be made available over the counter — but it's unclear whether they'll be able to follow through on those promises …
Read more on Washington Times

Over-the-counter Laxatives
As an example, in January 2014 the US Food and Drug Administration (FDA) released a safety warning about OTC sodium phosphate osmotic laxatives. The FDA warned that in rare instances, using more than 1 dose in 24 hours of these laxatives could …
Read more on JAMA: The Journal of the American Medical Association

December 31, 2014

FDA holds hearing on OTC drug review process; accepting comments until May 12

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)

Two Generic Versions of ADHD Drug Not as Effective: FDA – WebMD
The generic versions were approved by the FDA on the basis that they released the drug in the body over a period of 10 to 12 hours, to achieve the same effect as a three-times-per-day dose of immediate-release methylphenidate hydrochloride. But in some …
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'Boxed Warning' Added to Fibroid Removal Devices
The new warning will let surgeons and patients know that "uterine tissue may contain unsuspected cancer [and] the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients," the FDA …
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Steer Clear of Cold Meds for Babies, FDA Advises
WEDNESDAY, Nov. 26, 2014 (HealthDay News) — Most babies and young children don't need medicines if they have a cold, the U.S. Food and Drug Administration says. Over-the-counter (OTC) cold and cough medicine should not be given to children …
Read more on Philly.com

December 26, 2014

FDA Approves New Meningitis Vaccine

FDA Approves New Meningitis Vaccine
"Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in an agency …
Read more on WebMD

FDA Recommendations Aim to Make Liquid Acetaminophen Safer for Children
In August 2013, for example, the Consumer Healthcare Products Association (CHPA) petitioned FDA to make it easier to label over-the-counter (OTC) acetaminophen products in such a way as to make it easier to provide accurate doses to those same …
Read more on Regulatory Focus