FDA Related News

Medical Devices

Viveve 2.0 Cryogen-Cooled Monopolar RF Device Cleared

FDA clears a Viveve Medical 510(k) for the companys next-generation Viveve 2.0 cryogen-cooled monopolar radiofrequency system for use in general surgi...

Biologics

Florida Court Order Shuts Down Stem Cell Clinics

A Florida federal court issues an order that stops U.S. Stem Cell Clinic, of Weston, FL, and U.S. Stem Cell Inc., of Sunrise, FL, from manufacturing o...

Human Drugs

FDA Clarifies FDA-1571 Completion

CDER Office of New Drugs team leader Paul Phillips explains when research or commercial IND should be used in completing an FDA-1571.

Human Drugs

FDA Warns Akorn on Somerset Facility

FDA warns Akorn following an inspection at its Somerset, NJ, drug manufacturing facility.

Human Drugs

Acer Therapeutics Complete Response on Edsivo NDA

FDA issues Acer Therapeutics a complete response letter on its NDA for Edsivo (celiprolol) for treating vascular Ehlers-Danlos syndrome (vEDS).

Human Drugs

House Committee Asks Opioid Briefing

The House Energy and Commerce Committee asks for an FDA briefing on two opioid and fentanyl use and abuse issues.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes International Hospital Products, Rxhomeo Private Ltd. and Xian Livingbond Nonwoven Prod...

Human Drugs

FDA Rejects Daiichi Sankyo Quizartinib NDA

FDA issues Daiichi Sankyo a complete response letter on its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid le...

Medical Devices

QS Violations at International Hospital Products

FDA warns International Hospital Products about Quality System violations in its manufacturing of bowel decompression tubes.

Comments on Voluntary Recall Guidance

Five stakeholders comment on an FDA draft guidance on initiating a voluntary regulated product recall.