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BioWorld - Tuesday, May 24, 2022
Home » Topics » Regulatory

Regulatory
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U.S. Capitol and $100 bills

US lawmakers question budget fulcrum for ARPA-H, NIH

May 11, 2022
By Mari Serebrov
No Comments
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.
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Regulatory actions for May 11, 2022

May 11, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inex Innovate, Neuronetics.
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Regulatory actions for May 11, 2022

May 11, 2022
No Comments
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.
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Digital illustration of U.S., coronavirus

Contamination at root of class I recall of Mesa Biotech’s Accula COVID test

May 10, 2022
By Mark McCarty
No Comments
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.
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MDIC project brings use of RWE one day closer to routine regulatory practice

May 10, 2022
By Mark McCarty
No Comments
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.
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Fraud blocks under magnifying glass

Patient assistance programs attractive fraud target

May 10, 2022
By Mari Serebrov
No Comments
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.
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Global vaccine.png

WTO’s IP waiver reaches final stretch

May 10, 2022
By Mari Serebrov
No Comments
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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US Oversight report sheds light on Emergent GMP issues

May 10, 2022
By Mari Serebrov
No Comments
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
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Regulatory actions for May 10, 2022

May 10, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Elpiscience, Logicbio, Resverlogix, Selection, Teva, Therapeutics Solutions.
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FDA announces investigation into Fresenius hemodialysis units

May 9, 2022
By Mark McCarty
No Comments
The U.S. FDA reported it is evaluating the potential for exposure to some chemicals associated with the use of several models of hemodialysis machines made by Fresenius Medical Care Inc., of Waltham, Mass., including units that are no longer in production.
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