Shrimp Recall Update as FDA Sets Risk Level

Thousands of units have were potentially contaminated with a radioactive substance, which can increase the risk of cancer.

FDA Moves Toward Faster Drug Approvals

FDA Commissioner Dr. Marty Makary and his top deputy, Dr. Vinay Prasad, detailed the plan Feb. 18 in The New England Journal of Medicine. The move is the latest in a series of FDA efforts to eliminate ...

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

FDA accepts Sibel Health’s Aria sensor for COA qualification

Sibel Health has received acceptance from the US Food and Drug Administration (FDA) into the clinical outcome assessment (COA ...

inHarmony Announces FDA Registration Across Vibroacoustic and Red Light Therapy Product Lines

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...

Flour recall update as FDA sets risk level

Woodland Foods issued a recall for its Gourmet Arrowroot Flour on January 16 due to possible foreign material contamination.
CURE

FDA Approves Calquence Plus Venclexta for CLL and SLL

The Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) tablets and capsules in combination with Venclexta (venetoclax) for adults with chronic lymphocytic leukemia (CLL) or ...