PARIS – The new European regulation on medical devices came into force on May 26, 2021, one year later than planned, due to the COVID-19 pandemic. This European medical device regulation (MDR) modifies the conformity assessment procedure for medical devices in the 27 countries of the European Union, repealing two council directives implemented in the early 1990s.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Imcyse.
The U.S. Center for Medicare & Medicaid Services (CMS) opened a 30-day comment window on its proposed national coverage determination (NCD) to limit Medicare access to monoclonal antibodies targeting amyloid beta in Alzheimer’s disease (AD) only in clinical trials. Biogen Inc., clearly the target, along with its AD treatment Aduhelm (aducanumab), was among the first to respond.
Robert Califf moved a step closer to his second stint as head of the U.S. FDA when the Senate Health, Education, Labor and Pensions (HELP) Committee voted 13-8 Jan. 13 to favorably send his nomination to the full Senate for a confirmation vote.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Co-Diagnostics, Cosara, G-Tech Medical, Mentor, Wavegate.
Hoping to improve Europe’s clinical trial environment, EU officials launched an initiative Jan. 13 to transform how clinical trials are designed and conducted.
Olga Torres, co-owner of Miami-based Unlimited Medical Research, pleaded guilty Jan. 12 to obstructing a 2017 FDA inspection in connection with an alleged scheme to falsify data in a clinical trial evaluating an asthma drug for children.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Ascendis, Atai, Basilea, Cellular, Denali, Edesa, GSK, Hutchmed, Jeil, Mitsubishi, Novavax, Pharmather, Rockwell, SK, Vir.
Abbott Laboratories received FDA 510(k) clearance for the Ensite X EP system with Ensite omnipolar technology, the company’s cardiac mapping platform. The system, which is used to identify and treat abnormal heart rhythms such as atrial fibrillation, produces detailed three-dimensional maps of the heart to guide physicians performing ablation procedures.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
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