Government
The FDA is often publishing draft guidelines and asking for expert feedback on that guidance. It’s been a busy week in this regard, with several areas of healthcare and drug development and manufacturing being covered by the agency. Here’s a look.
Prior to being acquired by Medtronic, the two companies were involved in what the DOJ called kickback schemes to encourage unauthorized use of a medical device.
It should come as no surprise that not all information on the internet is reliable. It’s a largely unregulated wild, wild west that allows for anyone to put up any content they wish to. Which can be a particular problem when it comes to health-related content.
Novartis’ gene therapy treatment for spinal muscular atrophy could see approval as early as May of this year after the U.S. Food and Drug Administration granted AVXS-101, now dubbed Zolgensma, priority review.
Shareholders raise concern over the fairness of the reverse merger and question potential conflicts of interest of OvaScience’s co-founder.
A report from the Government Accountability Office said the FDA failed to live up to the legal requirements when approving drugs under a rare disease designation.
Florida-based Catalyst Pharma won regulatory approval for its treatment of a rare autoimmune disorder called Lambert-Eaton myasthenic syndrome (LEMS). The U.S. Food and Drug Administration approval of the new oral drug, Firdapse (amifampridine), is the first ever approved for this disease.
He’s research has not been published in a peer-reviewed scientific journal yet. He made his announcement at the Second International Summit on Human Genome Editing earlier this week. The details of the research were met with widespread condemnation and criticism by researchers globally.
The FDA approved Xospata for adult AML patients who have a FLT3 mutation as detected by an FDA-approved test. Of the 19,000 people in the United States who are estimated to be diagnosed with AML this year, nearly 40 percent will have a FLT3 mutation.
The U.S. Food and Drug Administration (FDA) issued a warning letter to Faro Owiesy, a researcher and physician at the California-based Corona Doctors Medical Clinics, for violating a clinical hold. In addition, the agency warned Owiesy for giving an investigational drug to patients before an investigational new drug (IND) application was approved.
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