FDA Related News

Federal Register

Info Collection Extension Sought for Device eMDR Submissions

Federal Register notice: FDA submits a proposed extension for a collection of information on Medical Device Reporting: Electronic Submission Requireme...

Medical Devices

TransEnterix 510(k) for Robotic Microlaparoscopic Surgeries

TransEnterix files a 510(k) for additional Senhance System instruments, including 3mm diameter instruments for abdominal surgery.

Human Drugs

Consent Decree Against Delta Pharma

A northern Mississippi judge enters a consent decree of permanent injunction against Delta Pharma (Ripley, MS) and two company officials after failing...

Medical Devices

Draeger Medical Class 1 Recall of Infant Jaundice Meter

Draeger Medical Systems begins a Class 1 recall of its Draeger Jaundice Meter due to a device design flaw.

Human Drugs

FDA Approves Celixir IND for Cell Therapy for Heart Failure

FDA approves a Celixir IND for Heartcel, an immuno-modulatory progenitor cell therapy for treating adult heart failure.

Medical Devices

Maquet Datascope Recalls CardioSave Intra-aortic Balloon Pump

Maquet Datascope recalls its CardioSave Hybrid Intra-aortic Balloon Pump due to a design issue that allows fluid (e.g., saline) to seep into the devic...

Federal Register

Modifications to FDA Recognized Consensus Standards

Federal Register notice: FDA publishes modifications to its list of standards the agency recognizes for use in premarket reviews (FDA Recognized Conse...

Human Drugs

Formal Dispute Resolution Program Moved in CDER

CDER director Janet Woodcock says that administrative responsibility for the formal dispute resolution program has moved from the Office of New Drugs ...

Biotech Working Group Action Plan Coming

FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram say an agency working group is developing a plan for FDA efforts to promote biotech...

Human Drugs

FDA Computed PDUFA Fees Accurately: OIG

The HHS inspector general says an audit shows that FDA correctly computed PDUFA rates paid by drug companies.