The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift.
The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, BD, Medtronic, Mosie Baby, Olleyes.
Ractigen Therapeutics Co. Ltd. has submitted a clinical trial application in Australia seeking to conduct a phase I study of RAG-01, a small activating RNA (saRNA) drug candidate, in patients with non-muscle-invasive bladder cancer who have not responded to Bacillus Calmette-Guérin (BCG) therapy.
With the number of high-priced cell and gene therapies expected to grow dramatically over the next decade, U.S. Sen. Bill Cassidy (R-La.) is asking for input from patients, doctors, manufacturers, payers and policy wonks on how to pay for the treatments and ensure patient access when they become more mainstream across the ultra-rare disease spectrum.
The U.S. FDA has approved Novartis AG’s Fabhalta (iptacopan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disease that impairs blood cell production. This is the only factor B inhibitor of the immune system’s complement pathway and is expected to be on the market before December ends. Fabhalta has plenty of competition from already-approved therapies and more treatments are in development.
China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.
Neuronetics Inc. gained expanded approval in Japan for its transcranial magnetic stimulation (TMS) system to treat major depressive disorder called the Neurostar TMS, helping the Malvern, Pa.-based company increase its footprint in Asia.
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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