clinical trials
A dashboard of shame for delinquent trial documentarians
The FDA has launched a new dashboard that stores the preliminary notices sent to companies, universities, and researchers that didn't register their clinical trials or report study results. Regulators have sent about 120 of these "pre-notices" to investigators who didn't complete these steps. If they aren't addressed, the FDA can levy penalties against errant trial sponsors or investigators. Among the recipients of these pre-notices are Novartis, Bausch and Lomb, and the Georgetown University Medical Center.
This matters because without access to specific data, trial results can't be replicated — which is an important step in understanding how medicines work. Missing information can also impact treatment decisions and health care costs.
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rebranding
FDA chastens pet companies over antibiotics
The FDA has warned nine online pet suppliers, including Chewy, for carrying "illegally marketed" over-the-counter antimicrobial medicines — including penicillin, amoxicillin, tetracycline, and erythromycin. Regulators said that humans might be using some of the antimicrobials being sold online for pets — much like the pandemic trend of buying ivermectin online, Forbes writes. The primary concern is that unmitigated use of these medicines could further spike antibiotic resistance.
The suppliers have been given 15 days to respond to the agency with a plan to remove these medicines, or could face legal action or have their products taken away.
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