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A Nasal Spray For Depression? FDA Gives Its Approval
The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first ...
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On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use ...
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 ...
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 ...
Scilex FDA submission for ELYXYB acute pain treatment acknowledged
PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug ...
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 ...
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 ...