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 ...
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 ...
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.
Rigel Announces R289 Granted Orphan Drug Designation by the FDA for MDS
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and ...
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 ...
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 ...
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 ...
Lupin receives US FDA tentative approval for Ivacaftor Oral Granules
These granules, available in 25 mg, 50 mg, and 75 mg per unit dose packets, are a generic equivalent of Kalydeco Oral ...