FDA Related News

Medical Devices

Medtronic Ventilator Field Correction is Class 1

FDA says a Medtronic field corrective action for its Puritan Bennett 980 ventilator series is a Class 1 recall.

In Vitro Companion Device Labeling Guidance

FDA issues a guidance on class labeling for companion diagnostic products for classes of oncology therapeutic products.

Human Drugs

Mylan Expanding Valsartan Recall

FDA says Mylan expands its recall of several types of valsartan-containing products.

Medical Devices

FDA New Approach to Regulating In Vitro Tests

FDA commissioner Scott Gottlieb and other agency leaders call for a new unified approach to regulation of in vitro clinical tests.

Medical Devices

POPS! Blood Glucose Monitoring Device

FDA clears a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system.

Human Drugs

Tris Pharma Recalls Infant Ibuprofen

Tris Pharma recalls three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concen...

Human Drugs

FDA Wants Food Handler Antiseptic Product Info

FDA opens a docket for stakeholder comments and data on the safety and effectiveness of antiseptic products intended for use in commercial or regulate...

Yates Memo Accountability Eased

Attorney Anne Walsh outlines Justice Department changes to the Yates memo on individual accountability in criminal and civil cases, including those in...

Human Drugs

FTC Supports FDA Deterring Petition Abuse

The Federal Trade Commission says it shares FDA concerns about abuse of the citizen petition process to delay approval of generic drugs and will work ...

Human Drugs

6 Observations in Gadea Biopharma FDA-483

FDA releases an FDA-483 with six observations from an inspection at Spains Gadea Biopharma.