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BioWorld - Sunday, May 22, 2022
Home » Topics » Regulatory

Regulatory
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Regulatory actions for May 19, 2022

May 19, 2022
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Neuromatrix.
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Regulatory actions for May 19, 2022

May 19, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelrx, Active Biotech, Alnylam, Calliditas, Cansino, Cytovation, Gedea.
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Prometheus Group hit with federal lawsuit claiming violation of FCA

May 18, 2022
By Mark McCarty
No Comments
The U.S. Department of Justice (DOJ) has filed a complaint in U.S. district court related to marketing of a pelvic muscle rehabilitation system by the Prometheus Group of Raleigh, N.C., stating that the company encouraged health care professionals to reuse rectal pressure sensors and anorectal manometry catheters on multiple patients.
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Phlebotomist draws blood from patient

OIG says phlebotomy draw fee arrangement would run afoul of Anti-Kickback Statute

May 18, 2022
By Mark McCarty
No Comments
Clinical laboratories and hospitals have routine commercial interactions, and most of those are entirely legal, but this is not always the case. The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services recently decreed that an arrangement in which the hospital pays the lab for blood specimen collection handling services, or a “draw fee,” would not be permissible under the Anti-Kickback Statute (AKS), reinforcing an existing understanding that such activities present a significant legal hazard for operators of clinical labs.
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FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
No Comments
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
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Patient assistance programs will live to see another year

May 18, 2022
By Mari Serebrov
No Comments
A U.S. district court slapped down a controversial Department of Health and Human Services rule that threatened the future of biopharma companies’ patient assistance programs, which are intended to help patients cover their out-of-pocket costs for pricy drugs.
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Global pandemic threat

Too little, too late: WHO panel says the world is vulnerable to another pandemic

May 18, 2022
By Lee Landenberger
No Comments
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
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Regulatory actions for May 18, 2022

May 18, 2022
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icad, Olympus, Robocath.
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Regulatory actions for May 18, 2022

May 18, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ananda, Biontech, Cytokinetics, Gilead, Huyabio, Incannex, Janssen, Nouscom, Pfizer, Sorrento, Teva.
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Senate user fee bill adds VALID Act despite omission in House user fee bill

May 17, 2022
By Mark McCarty
No Comments
The Senate Health, Education, Labor and Pensions (HELP) Committee has posted its version of U.S. FDA user fee legislation, a bill that echoes many of the primary features of the version already at play in the House of Representatives. One critical difference is that the Senate bill includes legislation that would enable the FDA to regulate lab-developed tests (LDTs), the so-called Verifying Accurate, Leading-edge IVCT Development (VALID) Act, the omission of which from the House bill ruffled a few feathers. The American Clinical Laboratory Association (ACLA) responded to the Senate bill with a May 17 statement applauding the inclusion of the VALID Act in the Senate user fee bill.
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