BioSpace7d
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 Supra28d
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 ...
JD Supra11d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
MedCity News5d
Navigating Complex Regulatory Landscapes in the Biopharmaceutical Industry
For example, the US Food and Drug Administration (FDA) and the European Medicines ... a critical factor in the accomplishment of the regulatory process. This implies that potential regulatory ...
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 ...
Healio2d
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 Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool
Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their ...
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 ...
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 ...
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 ...
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 ...
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 ...