FDA Related News

Human Drugs

All Companies Stopping Isoxsuprine Distribution

FDA says all manufacturers and labelers of isoxsuprine HCl products have agreed to cease distribution of them.

Medical Devices

FDA Patient Cybersecurity Best Practices Video

FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.

Human Drugs

3 Observations in Atlas Pharmaceuticals FDA-483

FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, AZ.

Medical Devices

Flume Balloon Urinary Catheter Cleared

FDA clears a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter.

Medical Devices

Woodcock Sets High Priority for OTC Covid Tests

FDA acting commissioner Janet Woodcock testifies before Congress about an agency priority to increase the availability of over-the-counter Covid-19 ho...

Human Drugs

FDA Updates Hill on Covid Therapies, Inspections

FDA testimony at a Senate hearing on Covid-19 discusses the unprecedented number of new product submissions to fight the disease and new manufacturing...

Diabetes Treatment Goal Can Cause Problems: Reuters

A Reuters series documents the role diabetes drug marketing techniques played in a significant increase in cases of hypoglycemia among diabetics tryin...

Human Drugs

FDA Fast Track for TransThera Drug

FDA grants fast track designation to TransThera Sciences experimental Phase 2 cholangiocarcinoma drug.

Human Drugs

10-item FDA-483 to Innoveix Pharmaceuticals

An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firms GMPs for sterile drug products.

Medical Devices

Software Function Premarket Submission Guidance

FDA publishes a draft guidance on recommended documentation for premarket submissions of medical device software functions.