COVID trial vaccines may be inadequate, some FDA advisors fear
By
Alicia Lasek
Oct 26, 2020
The current vaccine trials may be too focused on mild rather than severe disease, some advisors contend. But their arguments got pushback in a meeting streamed on the agency’s YouTube channel.
Masks arrive from ‘dubious’ sources, bearing false FDA certificates: report
By
Alicia Lasek
Jul 21, 2020
In a rush to meet demand for face masks and respirators, some manufacturers have turned out poor quality products while claiming federal approval, according to a new report.
Non-surgical face masks are not PPE, feds insist
By
Alicia Lasek
Apr 28, 2020
“Questions and concerns” about a recent emergency use authorization have prompted the FDA to clarify its guidance about face coverings.
Devices marketed as CPAP sanitizers may be unsafe, FDA warns
By
Alicia Lasek
Feb 28, 2020
Devices that claim to disinfect and sanitize CPAP machines with ozone gas and UV light are tied to health risks, the agency says.
Clinical Briefs for Thursday, January 2
By
Alicia Lasek
Jan 01, 2020
First generics of blood thinner Eliquis approved… FDA receives $91 million funding increase for 2020 … Few pharmacies provide antibiotic disposal instructions, survey shows
Promising antidepressant fails in late-stage trial
By
Alicia Lasek
Dec 05, 2019
Fast-tracked antidepressant Sage-217 failed to outperform a placebo in a stage 3 trial, according to its developer.
Clinical Briefs for Friday, December 6
By
Alicia Lasek
Dec 05, 2019
Opinion: FDA’s lax generic drug oversight puts seniors at risk … Study supports non-drug treatment for early diabetes symptoms … Bipartisan bill would create Office of Alzheimer’s Disease in Florida...
Reducing risk with new prescriptions
By
Larry Galluzzo
Dec 08, 2014
A report by the Food and Drug Administration found that individuals aged 65 to 69 years old take nearly 14 prescription medications per day, while individuals aged 80 to 84 take an average of 18 prescription...
FDA approves marketing of coronary device
Dec 02, 2014
The Food and Drug Administration has reviewed HeartFlow FFR-CT software, which lets healthcare professionals non-invasively evaluate blood flow in coronary arteries.
Two medications are approved by FDA
By
Elizabeth Newman
Aug 01, 2014
The U.S. Food and Drug Administration approved two medications in June that may benefit long-term care patients.