The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
Category Archives: Drug Safety Information Podcasts
FDA seeks permanent injunction against Pharmaceutical Innovations, Inc.
The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.
The FDA takes steps to strengthen cybersecurity of medical devices
To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.
FDA awards grants to stimulate drug, device development for rare diseases
The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.
U.S. Marshals seize botanical substance kratom from southern California facility
U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.
NIH and FDA win top award for intellectual property licensing of meningitis vaccine
The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.
FDA clears glucose monitoring system for use in hospital critical care units
Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.
FDA food safety challenge to spur new technologies for fighting foodborne illness
The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.
FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sample
The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.