US FDA expands use of Avadel's sleep disorder drug to ages 7 and up
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...
FDA identifies food safety issues at Delta food preparation facility
Passengers on 200 Delta flights were denied in-flight meal service after food safety issues were discovered in the airline's ...
FDA Has Recalled Thousands of Bottles of Antidepressant Duloxetine, Sold Under Brand Name Cymbalta: Here’s Why
The Duloxetine Delayed-Release Capsules' voluntary recall began on Oct. 10 after the FDA deemed the medication the ...
US FDA declines to approve Camurus' rare hormone disorder drug
The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...
California leads the way on regulation of food additives
Food companies exploit a loophole in the FDA’s rules that let them self-determine an additive’s safety, yielding obvious ...
Convenience Store News14h
FDA Seizes 3 Million Unauthorized E-Cigarettes in Joint Federal Operation
The Food and Drug Administration, in collaboration with the U.S. Customs and Border Protection (CBP), seized about three ...
STAT7h
Novo asks FDA to bar compounders from making Ozempic copies
The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...
MLive10h
7,100 bottles of antidepressant recalled by FDA now in 2nd highest risk class
Duloxetine Delayed-Release Capsules were recalled because the pills may contain high levels of a cancer-causing chemical.
Pfizer Receives FDA Approval for RSV Vaccine
Abrysvo can prevent lower respiratory tract disease caused by RSV for people between the ages of 18 and 59 who are at ...
STAT14h
Michelle Tarver to lead FDA medical device center
Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an ...
JD Supra14h
FDA lists top 10 artificial intelligence regulatory concerns
FDA published a JAMA article on October 15, 2024, describing several areas of focus for regulation of AI used in the medical products. The JAMA article follows a June 2024 FDA blog post by Troy Tazbaz ...
BioPharma Dive10h
FDA names Tarver as new head of device center
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.