FDA Related News

Human Drugs

FDA Approves Cornerstone Pivotal Trial on Leukemia

FDA gives Cornerstone Pharmaceuticals a green light to conduct pivotal trials of its lead compound, CPI-613, in patients with acute myeloid leukemia a...

Human Drugs

Sanders, Cummings Ask for Emflaza Pricing Info

Sen. Bernie Sanders and Rep. Elijah Cummings ask PTC Therapeutics for proposed pricing information for its newly acquired Emflaza.

Medical Devices

FDA Approves Alcon New ReSTOR Intraocular Lens

FDA approves Alcons new AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ActiveFocus design for uncompromised distance vision and presbyo...

Medical Devices

AdvaMedDx Reviewing Lab Test Draft Bill

AdvaMedDx says it is reviewing a draft of the Diagnostic Accuracy and Innovation Act and urges Congress to address diagnostic regulatory issues.

Human Drugs

FDA Approves EMD Serono Carcinoma Drug

FDA grants EMD Serono accelerated approval for Bavencio (avelumab) for treating adults and pediatric patients 12 years and older with metastatic Merke...

Medical Devices

FDA Approves CeloNovas COBRA Stent System

FDA approves a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System.

Federal Register

CDRH Seeks Experiential Learning Program Players

Federal Register notice: CDRH announces its 2017 Experiential Learning Program, a training component that is intended to provide Center staff with an ...

Human Drugs

FDA Warns USV About CGMP Violations at Daman

FDA warns Indias USV about CGMP and data integrity problems at its Daman drug manufacturing facility.

Attorney Disputes Increased Liability in Off-label Promotion

Attorney James Beck challenges the view that legalizing off-label drug and medical device promotion could result in increased company liability.

Human Drugs

Califf Heading New Research Foundation

Former FDA commissioner Robert Califf says he will chair the board of the new People-Centered Research Foundation created to sustain and expand a nati...