FDA Related News

Federal Register

Guide on Demonstrating Biosimilar Interchangeability

Federal Register notice: FDA makes available a final guidance entitled Considerations in Demonstrating Interchangeability With a Reference Product.

Medical Devices

Haemonetics TEG 6s Analyzer Cleared for Trauma Setting

FDA clears a Haemonetics 510(k) to expand the medical indication of its TEG 6s Hemostasis Analyzer System for use in adult trauma settings.

Human Drugs

Bershtel Enterprises CGMP Violations

FDA warns Bershtel Enterprises about CGMP violations in its production of finished drugs as a contractor to its customers.

SCOTUS Gives Whistleblowers More Time to File

The Supreme Court says whistleblowers in cases where the federal government does not intervene can have a longer period of time in which to file their...

Human Drugs

Repeat CGMP Violations at Petra Hygienic

FDA warns Canadas Petra Hygienic Systems about repeat CGMP violations in its production of finished drugs.

Human Drugs

5 Homeopathic Drug Companies Warned on CGMPs

FDA warns five homeopathic drug companies about CGMP violations.

Human Drugs

State of Pharmaceutical Quality Report Out

FDA releases its yearly State of Pharmaceutical Quality report.

Medical Devices

Murray Asks Olympus for Duodenoscope Info

Senate HELP Committee ranking Democrat Patty Murray asks Olympus to answer questions arising from FDA data showing its closed-channel duodenoscopes ma...

Medical Devices

eMurmur Heart Murmur ID Solution Cleared

FDA clears an eMurmur 510(k) for the eMurmur ID Solution for detecting heart murmurs.

Human Drugs

Broader Use for Pediatric Cancer Trial Eligibility: PhRMA

PhRMA tells FDA that a draft guidance on Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients should be applicable across ot...