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 …
Read more on WebMD
'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 …
Read more on WebMD
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
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 …
Read more on WebMD
'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 …
Read more on WebMD
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
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