Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeglea, Affamed, Bharat Biotech, Biocardia, Blue Earth, Fera, Gilead, Henlius, Medilink, Myovant, Ocugen, Paradigm, Poxel, Secura, Vistagen, Xortx.
Boston Scientific Corp.’s image-guided programming software, Vercise Neural Navigator with Stimview XT, got the green light from the FDA for use with the company’s deep brain stimulation (DBS) portfolio in patients with essential tremor or Parkinson’s disease. The software, developed in a collaboration with Brainlab AG, provides more sophisticated image-guided programming tools for personalization of the stimulation therapy, halving the time needed for adjustments and increasing precision.
Newstem Ltd. filed a presubmission to the U.S. FDA for a de novo request and an in vitro diagnostic device with the EMA for its Newstem software diagnostic device (NSDD). The bioinformatics-based platform is a personalized diagnostic to inform oncologists about the presence of mutations in tumors and predict a patients’ resistance to chemotherapy treatments. The technology utilizes specialized stem cells (haploid cells) that carry just one set of chromosomes.
The FDA program for third-party review of 510(k) applications was designed to take some of the load off the agency’s review staff and thus allow the agency to focus on more complex filings, but recent data suggest that the program has had only a modest effect on the FDA’s workload. The number of third-party reviews for the current and two previous fiscal years only modestly exceed the numbers from fiscal years 2018 and 2019, a conspicuous trend given the distractions at the FDA’s device arising from its work to manage the COVID-19 pandemic.
For the second time in four years, the FDA has issued a draft guidance for cybersecurity in premarket applications, just one of several actions undertaken recently by the U.S. federal government in connection with cybersecurity.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Boston Scientific, Novacyt, Transit Scientific.
The twos have it as the U.S. FDA’s Office of Prescription Drug Promotion, in its second untitled letter of the year, took Bausch Health Cos. Inc. to task over two promotions of its plaque psoriasis lotion, Duobrii (halobetasol propionate and tazarotene).
Making it a done deal, the European Council adopted proposals April 12 to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The U.K. plan to fix the market failure in antibiotics has taken a significant step forward with the publication of guidance estimating the value of two drugs to the National Health Service.
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