The FDA Will Test You Now
The agency makes a power grab to regulate lab tests like medical devices.
BioSpace14h
FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fire
Ahead of the FDA’s June target action date for Sarepta’s Duchenne muscular dystrophy gene therapy, ICER Chief Medical Officer David Rind blasted the regulator’s accelerated pathway in a JAMA viewpoint ...
FDA misses own deadline to propose ban on cancer-linked formaldehyde from hair relaxers
The government regulator said in October that it would propose a ban on the use of the chemical, which is commonly in hair ...
Oops They Did It Again: FDA Misses Deadline To Propose A Ban On Formaldehyde, The Chemical Often Used In Hair Relaxers
The FDA failed to release a proposal to ban formaldehyde this past April, similar to in 2021 when the agency missed their ...
Continued FDA testing finds no active bird flu virus in variety of dairy products
Ongoing testing of milk and dairy products by the US Food and Drug Administration has not found any active H5N1 bird flu ...
FDA says multistate E. coli outbreak tied to walnuts
Federal health officials are in the midst of looking into a multistate outbreak of E. coli infections that have been tied to ...
Yahoo1d
FDA has completed its testing for bird flu in milk, dairy products — and more
For Thursday, May 2, WGN’s Ben Bradley and Lourdes Duarte have the latest on new medical information, including: More ...
Wareable13h
Apple Watch AFib feature receives new FDA approval - can now be used in clinical studies
The atrial fibrillation feature on the Apple Watch has received new approval from the FDA, meaning it can now be used as part ...
FDA qualifies Apple Watch’s AFib history for use in clinical studies
The Apple Watch’s atrial fibrillation (AFib) history feature, which records and alerts the wearer’s relevant heart events, ...
FDA says bird flu tests show milk supply is safe
Health officials ordered testing amid concerns the virus that made dairy cows sick in nine states might have spread to their ...
Apple Watch feature becomes first digital health tech to receive this FDA approval
But perhaps even more notable is that the Apple Watch AFib feature becomes the first ever digital health technology to qualify under the FDA's MDDT program.
MedPage Today7h
Rare Pregnancy Problem Linked to Thiopurines, FDA Says
Use of thiopurines has been linked with a rare risk of intrahepatic cholestasis of pregnancy (ICP), primarily in patients taking the drugs for inflammatory bowel disease or lupus, the FDA said in a ...