STAT4h
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
STAT7d
Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
FDA Sets New Levels for Toxic Lead in Baby Food
The FDA's new standards for toxic lead target processed baby foods such as jarred fruits, vegetables, yogurts and dry cereals ...
PureTech Drug Gets FDA Fast-Track Designation for Leukemia
The biotherapeutics company said the treatment, LYT-200, is being evaluated in two ongoing clinical trials. It was previously granted orphan drug designation for the treatment of acute myeloid ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
FDA disappoints child advocates with its new limit on lead in baby food
For the first time, the US Food and Drug Administration has set a limit on the amount of lead that can be in baby foods, but ...
JD Supra18h
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
FDA limits toxic lead in baby food, but Illinois rep says more should be done
The Food and Drug Administration put guidelines in place to curb the amount of lead in baby food, but some like one Illinois ...
Johnson & Johnson Gets FDA Priority Review of Nipocalimab in Generalized Myasthenia Gravis
Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.
FDA's Food Safety Inspections Struggle Amid Staffing Shortfall
The FDA has failed to meet its mandated targets for domestic and foreign food safety inspections since fiscal 2018, the US ...
JD Supra17h
FDA’s Fresh Take on Use of “Healthy” in Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition ...
Convenience Store News16h
FDA Issues Final Guidance on Testing for Industry Use in Tobacco Product Applications
The Food and Drug Administration on Monday issued a guidance for the tobacco industry entitled Validation and Verification of ...