Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Ascletis, Cue, Eli Lilly, Immuron, Incyte, Iterum, Kiromic, Regulus, Spine, Veru.
The legislation that would renew a number of FDA user fee programs, the Food and Drug Amendments Act (FDA Act) of 2022, has passed the first legislative hurdle in a subcommittee of the U.S. House of Representatives, but there are several issues with the bill. According to members of the subcommittee, the issues include an absence of provisions for medical device servicing, and the absence of legislation for FDA regulation of lab-developed tests (LDTs), issues that are unlikely to be resolved before the legislation is passed out of the House.
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
With its focus on transformative high-risk, high-reward research to drive biomedical breakthroughs, the new Advanced Research Projects Agency for Health (ARPA-H) may be a good concept, but it shouldn’t come at the expense of increased investment in basic research at the NIH, according to the bipartisan leadership of U.S. House appropriators.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inex Innovate, Neuronetics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Eisai, Gilead, Kadmon, Moleculin, Neogene, Novo Nordisk, Turning Point, Zai Lab.
The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
The Medical Device Innovation Consortium (MDIC) ran a series of 14 test cases to evaluate the value of real-world evidence (RWE) for regulatory decision making, but there were several sources of drag in this first phase of the project, such as a lack of availability of unique device identifiers (UDIs) for some devices.
News of government prosecutors actively going after individuals for defrauding the U.S. health care system has become commonplace, but the government’s focus on criminally prosecuting fraud against Medicare, Medicaid and other government programs could make biopharma companies’ patient assistance programs a more attractive target.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
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