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If a device sponsor wishes to appeal a rejection from the FDA’s Center for Devices and Radiological Health (CDRH), it should follow the chain of command to the next level up from the official who made the decision, the agency said in a final guidance released yesterday. Read More
Minnesota device developer Cardiovascular Systems (CSI) has unveiled plans to expand its reach in thrombectomy devices by partnering with California-based Innova Vascular. Read More
The FDA has issued a Form 483 to medical device and biologics manufacturer Lonza based on an inspection last November of the company’s facility in Walkersville, Md. Read More
The Friends of Cancer Research (FOCR) is urging the FDA to better coordinate simultaneous approval of new cancer drugs and companion diagnostics, and to focus on more speedy approval of diagnostics for rare cancer biomarkers. Read More
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
Boston, Mass.-based Global Protection has received de novo authorization from the FDA to expand the intended use claim of its ONE and myONE brand condoms to include anal sex, with the agency stressing its commitment to the needs of diverse populations. Read More
An FDA remote inspection can carry major drawbacks, including that they may last longer than an in-person visit and that the FDA doesn’t consider them to be a full substitute for an on-site inspection. Read More
The FDA has issued a Form 483 to Becton Dickinson (BD) Caribe based on an inspection last November of the devicemaker’s facility in Juncos, Puerto Rico. Read More