FDA’s plan to propose ban on formaldehyde in hair-straightening products remains in limbo under Trump administration
A plan for the US Food and Drug Administration to propose banning formaldehyde and certain formaldehyde-releasing chemicals ...
BioSpace8d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
JD Supra12d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
JD Supra29d
Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110
The FDA released this guidance as part of the Center for Drug Evaluation and Research’s Framework for Regulatory Advanced ... response efforts involving in-process sampling given the vagueness ...
Rolling Out12d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
Healio3d
Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...
Roll Call25d
FDA authorizes first nicotine pouches
The Food and Drug Administration ... the same regulatory process as a tobacco product. Zyn is a subsidiary of Philip Morris International. “To receive marketing authorizations, the FDA must ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
CBS News26d
FDA moves to ban Red 3, citing concern over cancer in some animals
The Food and Drug Administration announced ... in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years ...
Why Some Food Additives Banned in Europe Are Still on U.S. Shelves
In the U.S., it’s still found in many confections, including Sour Patch Kids watermelon candies, Hostess chocolate cupcakes ...