JD Supra51m
FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models
On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Medicare drug price negotiations to target Ozempic, Wegovy and other drugs
The hugely popular medications Ozempic and Wegovy​, used for diabetes and weight loss, will be included in the next round of ...
BioPharma Dive5d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Ozempic and Wegovy selected for next round of Medicare drug price negotiations
Ozempic and Wegovy, the blockbuster but costly GLP-1 drugs often used for weight loss, are among the 15 medications that will ...
Food shoppers could see nutrition facts on the front, as FDA unveils proposed packaging rules
The Food and Drug Administration released on Tuesday its long-awaited proposal to require food manufacturers to put some ...
How will AI revolutionize drug development?
Most AI researchers can tackle specific tasks in the drug development process when provided with high-quality data and ...
What Foods Will Be Impacted by FDA’s Ban on Red Dye No. 3—And What Could Replace It
T he U.S. Food and Drug Administration (FDA) banned the use of Red Dye No. 3 in food and ingested drugs on Wednesday, more ...
Medpage Today on MSN4d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
JD Supra11d
FDA issues Guidance on Interim Animal Food Ingredient Consultation (AFIC) Process
The AFIC process is intended to help FDA identify any potential safety concerns associated with animal food ingredients, provide information to the public, request input on animal food ingredients ...
HealthDay on MSN3d
FDA Proposes Nicotine Cap To Help Curb Cigarette Addiction
A rather historic U.S. Food and Drug Administration (FDA) proposal aims to make cigarettes and other tobacco product ...
BioSpace5d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Opinion
FDA bans red dye No. 3 far too late and after officials knew it was dangerous | Opinion
On Wednesday, the Food and Drug Administration banned red dye No. 3, additive in food that was banned from cosmetics in 1990.