FDA Related News

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.

FDA General

AbbVies Venclexta Approved for Combo Use

FDA approves an AbbVies Venclexta (venetoclax tablets) in combination with rituximab for treating patients with chronic lymphocytic leukemia or small ...

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.

Medical Devices

FDA Clears K2Ms Ozark Cervical Plate Systems

FDA clears a K2M Group Holdings 510(k) for its Ozark Cervical Plate Systems for anterior screw fixation to the cervical spine in patients with degener...

Medical Devices

Changes in Sequencing Guidances Explained

A CDRH Webinar reviews changes made to next generation sequencing guidances.

Human Drugs

AAM Wants Case-by-Case 505(b)(2) Determinations

The Association for Accessible Medicines urges FDA to adopt a case-by-case approach in determining whether a 505(b(2) biologic should be deemed to be ...