COVID-19 - March 12, 2020
The FDA is postponing most foreign inspections in response to the coronavirus outbreak
FDA has provided an update on the status of its inspections outside of the US in response to the COVID-19 outbreak and announced that it is postponing most foreign inspections through April, effective immediately. The Food and Drug Administration (FDA) said Tuesday that it is postponing most inspections of foreign manufacturers of pharmaceutical products, medical […]
Global report - October 5, 2016
EU-US collaboration to combat rare diseases
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on rare diseases to share experiences and best practices on each other’s regulatory approach to the development of medicines for these diseases. While rare diseases are estimated to affect 30 million people in the European […]
In a new job - March 9, 2016
Robert Califf named FDA Deputy Commissioner for Medical Products
U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., has appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco. In this position, Dr. Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics […]
Drug Development Pharma - August 17, 2015
Orexo’s ZUBSOLV approved
Orexo has announced that the US Food and Drug Administration has approved ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for ZUBSOLV, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase […]
MedTech Business - August 10, 2015
Elekta receives US 510(k) clearance
Elekta’s Leksell Gamma Knife® Icon™ radiosurgery system has received 510(k) clearance from the US Food and Drug Administration. Gamma Knife Icon represents the sixth generation of the company’s Leksell Gamma Knife system, a technology that has been in use worldwide and continually evolving since the 1980s. Gamma Knife radiosurgery is a gentler alternative to traditional […]
Drug Development Pharma - June 9, 2015
Janssen Submits BLA to FDA
Genmab A/S’s licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab for double refractory multiple myeloma. The submission is for using daratumumab to treat patients with multiple myeloma who have received at least three different lines of therapy […]
