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Home » Topics » Regulatory

Regulatory
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Woman on couch using tablet

Advertising and promotions still a major hazard for device makers

May 19, 2022
By Mark McCarty
Device makers do not engage in direct-to-consumer advertisement at the same pace as drug makers, but advertising and promotions are still a minefield of potential enforcement action for the unwary manufacturer. According to Jesse Atkins and Nate Downing of Gardner Law in Stillwater, Minn., even a minor skirmish with the FDA can result in an extensive review of standard operating procedures, a potentially expensive and time-consuming distraction from companies fighting for market share in the hotly contested U.S. market.
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Vial and three syringes

ACIP recommends giving US kids a boost

May 19, 2022
By Mari Serebrov
Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose.
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US FDA churns out more guidances, updates

May 19, 2022
Another spate of U.S. FDA guidances for prescription drug manufacturers includes updates for carton labeling, product-specific advice and recommendations on mitigating potential drug shortages.
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Regulatory actions for May 19, 2022

May 19, 2022
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
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
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
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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Aptima CMV Box

FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
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
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
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.
Read More
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