By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration have begun seeking stakeholder feedback for a proposed system to better evaluate registrants’ compliance with voluntary consensus standards. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
Food & Drug Administration (FDA)
Navigating the regulatory and development pathways for drug-device products
David Lee began his path to CEO of Lumicell in 1999, when his wife was diagnosed with cancer. She passed away in 2003, while Lee was working in the semiconductor industry. He decided it was time for a career change. More than a decade later, Lee holds the corner office at a company that is […]
Dr. Reddy’s liposomal doxorubicin wins FDA nod
Dr. Reddy’s Laboratories (NYSE:RDY) said today that the FDA approved its doxorubicin hydrochloride liposome injection for intravenous administration. The liposomal formulation is a therapeutic-equivalent generic version of the chemotherapeutic, Doxil. “This approval represents the 1st of its kind for Dr. Reddy’s in the complex depot injectables arena,” Alok Sonig, executive VP and head of the U.S. […]
Dr. Gottlieb’s first remarks to FDA staff
Remarks by Scott Gottlieb, M.D. FDA All Hands Meeting May 15, 2017 Silver Spring, MD It’s an honor to be here today and to be taking on this responsibility with all of you. You realize how special our mission of consumer protection and public health promotion is when you explain what we do to the children […]
AdvaMed unveils new tools to assess medical device value
AdvaMed today launched a new value initiative that includes extensive tables of questions to help medical device companies formulate value-based arguments. The value framework also includes tools specifically designed for diagnostic technologies, as well as report on understanding evidence and use cases. “Value” has become an important word in medtech in recent years as government and […]
GSK dodges bullet after another generic Advair competitor is denied
GlaxoSmithKline (NYSE:GSK) will not likely face generic competition to its lung drug Advair in the US this year. Yesterday, the FDA denied the application for a 2nd generic competitor. Hikma Pharmaceuticals (LON:HIK) disclosed today that the FDA decided not to approve its version of the inhaled asthma treatment, due to “major” problems with the application. This comes […]
FDA approves first ALS treatment in over 2 decades
The FDA recently announced that it has approved the drug Radicava (edaravone) to help treat patients who have amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a progressive neurodegenerative disease that affects the nerve cells in the brain and spinal cord, according to the ALS Association. Motor neurons in the brain […]
Medtech stories we missed this week: May 5, 2017
From Biomerics’s $38.5 million expansion in Salt Lake City to new study results and partnerships, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Biomerics opening new corporate HQ Biomerics announced in a May 1 press release that it is moving its corporate headquarters in Salt Lake City. The […]
FDA OKs BioDelivery Sciences’ Bunavail opioid dependence film
BioDelivery Sciences International (NSDQ:BDSI) said today that the FDA approved a supplemental new drug application for its Bunavail buprenorphine and naloxone buccal film. The revised indication allows patients to use the product to initiate buprenorphine treatment for opioid dependence. Induction is the initial process by which a patient transitions from abusing an opioid to buprenorphine […]
GE Healthcare wins FDA nod for Visipaque coronary CT angiography injection
GE Healthcare (NYSE:GE) said today that it won an indication approval from the FDA for its Visipaque injection imaging agent. The 320 milligram iodine per milliliter injection is an iso-osmolar agent that the federal watchdog approved for use in coronary computed tomography angiography. The new indication allows doctors to image coronary arteries of patients to help […]
