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Home » Topics » Regulatory

Regulatory
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US omnibus spending bill omits legislation for FDA regulation of lab-developed tests

Dec. 21, 2022
By Mark McCarty
With yet another deadline looming for passage of spending bills for the U.S. federal budget, Congress has drafted an omnibus spending bill that would extend coverage of Medicare telehealth services. The problem with the legislation in the eyes of many stakeholders is that the Verifying Accurate Leading-edge IVCT Development (VALID) Act is not part of the package that must be passed by Dec. 23, an omission that leaves lab-developed tests (LDTs) in a nether world of regulatory ambiguity.
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Sciclone gets green light for naxitamab for patients with neuroblastoma in China

Dec. 21, 2022
By Doris Yu
Sciclone Pharmaceuticals Holdings Ltd. has obtained marketing approval in China for Danyelza (naxitamab) for patients with relapsed or refractory high-risk neuroblastoma. The drug, in combination with granulocyte macrophage colony-stimulating factor, was approved to treat pediatric patients aged 1 and above, as well as adults, who have relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and have demonstrated a partial or minor response to prior therapy or stable disease.
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Regulatory actions for Dec. 21, 2022

Dec. 21, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Foundation Medicine, Venus Concept.
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Regulatory actions for Dec. 21, 2022

Dec. 21, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Entrada, Horizon, Idorsia, Invectys, Iveric, Kira, Maia, Merck & Co., Mitsubishi Tanabe, NS, Seagen, Skye.
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FDA reissues inspection interference guidance to include device manufacturing facilities

Dec. 20, 2022
By Mark McCarty
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
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SARS-CoV-2 illustration turns from blue to red

WTO divided over expanding COVID-19 IP waiver

Dec. 20, 2022
By Mari Serebrov
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
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China and U.S. flags

US PCAOB compliance a historic first in China

Dec. 20, 2022
By Mari Serebrov
Chinese authorities this year for the first time allowed access for complete U.S. Public Company Accounting Oversight Board (PCAOB) audit inspections and investigations of PCAOB-registered public accounting firms headquartered in China and Hong Kong, in accordance with U.S. securities law.
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FDA deems Teleflex/Arrow recall of catheter kits a class I event

Sensititre plates recalled
Dec. 20, 2022
By Mark McCarty
The FDA posted a recall announcement for two catheter kits made by Arrow International LLC, a subsidiary of Wayne, Pa.-based Teleflex Inc., due to problems with the connectors used in the kits. While no injuries or deaths have been reported, the problem could lead to embolism and/or delayed delivery of needed therapeutic fluids to patients, making this a class I recall due to the risk of injury and death.
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Regulatory actions for Dec. 20, 2022

Dec. 20, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Surglasses.
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Regulatory actions for Dec. 20, 2022

Dec. 20, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Albireo, Arcutis, Ardelyx, Astrazeneca, Biocytogen, Bluebird, Daiichi Sankyo, Eagle, Eqrx, F2G, Ferring, HRA, Hutchmed, Neurophth, On Target, TG Immunopharma, Perrigo, Recbio.
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