JD Supra1d
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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
Supreme Court seems skeptical of court-shopping claim against vape makers
The FDA says vaping companies are improperly gaming the court system, filing claims in an appeals court they think will be sympathetic to them.
BioPharma Dive6d
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 ...
Hosted on MSN5d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
The FDA needs to strengthen guardrails to ensure its accelerated approval pathway is used appropriately, the HHS Office of ...
Becker's Hospital Review6d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
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 ...
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 ...
JD Supra13d
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 ...