FDA posts observations from AstraZeneca site inspection
The FDA posted to its site the observations made during an inspection of an AstraZeneca (AZN) manufacturing center that was conducted from May ...
JD Supra5h
Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?
As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...
FiercePharma9h
FDA hits pair of Indian API makers with warning letters, import alerts
From turning away inspectors to falsifying data and leaving "bare footprints" in production containers, two of the latest ...
What’s the Difference Between the FDA and the USDA?
Explaining America’s weirdly complicated food inspection system, including who regulates poultry and eggs and how Robert F.
Washington Examiner14d
Fentanyl-laced marijuana, horse tranquilizer, and nitazenes listed as top emerging drug threats in US
Lawmakers on Capitol Hill were briefed by drug experts about emerging illicit ... and so we’ve seen all of these things really need a regulated, inspected process,” Bouchard said.
National Fisherman14d
FDA falls short on foreign shrimp inspections
Citing the U.S. Government Accountability Office (GAO) in a report to Congress publicly released on Wednesday, Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply, ...
Pharmaceutical Technology14d
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing ...
The Hamilton Spectator15d
Patients using diabetes apps can miss critical alerts. Here’s how to make sure you’re getting them
The Food and Drug Administration said Wednesday it has received multiple reports of users missing or not hearing important medical alerts from their phones, leading to cases of dangerously low ...
Killeen Daily Herald15d
FDA Approves Susvimo for Diabetic Macular Edema
WEDNESDAY, Feb. 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema. Susvimo is the first and only ...
Daily Journal15d
Ex-Tulsa guard PJ Haggerty leads No. 17 Memphis to win
PJ Haggerty scored a game-high 23 points Wednesday night and No. 17 Memphis stayed atop the American Athletic Conference with an 83-71 win over visiting Tulsa. Dain Dainja stuffed the stat sheet ...