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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus, Cepheid, Neuromatrix.
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.
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.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Icad, Olympus, Robocath.
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