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Regulatory
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Regulatory actions for April 20, 2023

April 20, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cel-Sci, CSL, Nascent, SAB, Taiho, Zucara.
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Acting director of NIH says agency is wary of using march-in rights to control drug prices

April 19, 2023
By Mark McCarty
The annual U.S. budget scrum is well underway in Washington, with drug pricing a persistent theme on Capitol Hill. Lawrence Tabak, acting director of the National Institutes of Health (NIH), said NIH’s view is that federal government exercise of march-in rights “is not the instrument to regulate drug pricing” as it would alienate drug makers and their investors, but Tabak vowed that the appropriate use of march-in rights is the subject of intense focus at the Department of Health and Human Services.
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US Supreme Court grants another short stay in mifepristone challenge

April 19, 2023
Danco Laboratories LLC’s Mifeprex (mifepristone) and Genbiopro Inc.’s generic got another temporary reprieve April 19 from a court order that would tighten access to the abortion drug.
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Map of Australia with pills, vials and syringe

Australia begins first overhaul of its health technology assessment process in 30 years

April 19, 2023
By Tamra Sami
Australia’s Department of Health is seeking input from the public on the country’s health technology assessment process that informs decisions about what drugs or devices should be reimbursed and under what circumstances a therapy should be subsidized and at what cost to the taxpayer.
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Regulatory actions for April 19, 2023

April 19, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations:  Abbvie, Adverum, Avenue, Basilea, Biosyngen, Gamida, Huidagene, Hutchmed, Hyloris, Madrigal.
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FDA website and logo

FDA drops warning letters on Abbott’s Canadian operation and North American Diagnostics

April 19, 2023
By Mark McCarty
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product.
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Draeger scrambling to address poor adhesive used in ventilation systems

April 18, 2023
By Mark McCarty
Draeger Inc., of Telford, Pa., reported a recall of several lines of positive airway pressure (PAP) and other ventilation products in connection with problems seen in the adhesive used on breathing circuit components. Draeger said it has no reports of adverse events in connection with separation of the affected components during ventilation processes but has completed its testing of the corrective action and is working to replace the affected devices.
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Regulatory actions for April 18, 2023

April 18, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Hemovent, Masimo, Neuspera, Rapidai, Syantra.
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Court closed to Sanofi’s Epipen challenge

April 18, 2023
By Mari Serebrov
Sanofi SA’s antitrust challenge of Mylan Inc.’s “exclusionary conduct” in the epinephrine auto-injector market met the end of the road April 17 when the U.S. Supreme Court denied cert.
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Japanese money and medicine

Pharma groups urge Japan’s MHLW to reform pricing policies

April 18, 2023
By Tamra Sami
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs.
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