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Drug Regulation

All articles tagged with #drug regulation

Clarke’s Kratom Episode Pushes the Controversial Plant Into Regulatory Spotlight
health1 month ago

Clarke’s Kratom Episode Pushes the Controversial Plant Into Regulatory Spotlight

NBA forward Brandon Clarke’s Arkansas arrest over kratom capsules—he told deputies, 'it's just kratom'—highlights a fiercely debated, poorly regulated plant that critics say can be addictive and dangerous. With Tennessee and other states weighing bans, the FDA warns of serious risks, while Arkansas already criminalized kratom; Clarke later died in California, with toxicology results pending and officials not confirming kratom as a factor. The case underscores ongoing questions about kratom’s medical value, safety, and the integrity of industry practices and sponsorships in sports.

via The New York Times|
#7-oh#brandon-clarke#death
Melatonin's regulatory crossroads: drug status vs. sleep supplement
health1 month ago

Melatonin's regulatory crossroads: drug status vs. sleep supplement

Melatonin, a natural sleep hormone, is treated as a dietary supplement in the U.S. with limited pre-market safety testing, while other countries regulate it as a medication. Experts warn that variable labeling, unknown long‑term safety—especially for children—and potential misuse due to perceptions of harmlessness argue for tighter oversight or even drug status. A reclassification could improve dosing clarity and safety, but proponents contend it might limit access and raise costs; meanwhile, labeling guidelines exist but aren’t mandatory, and the regulation landscape remains unsettled.

via Live Science|
#drug-regulation#fda#health
FDA weighs loosening rules on unproven peptide injections
health2 months ago

FDA weighs loosening rules on unproven peptide injections

The FDA says it will convene a July advisory panel to decide whether seven popular but unproven peptide injections should be added to a list allowing pharmaceutical compounding, potentially easing restrictions. The move aligns with Health Secretary RFK Jr.’s push to loosen peptide regulations and the stance of MAHA supporters, though critics warn that most peptides lack safety data and could bypass traditional drug testing. Even if advisers approve, the agency must still complete formal rulemaking. Some peptides are banned by sports bodies and have previously been placed on restricted lists due to health risks, underscoring ongoing safety concerns around this market.

via PBS|
#drug-regulation#fda#health
Vinay Prasad's FDA tenure ends amid data-purity clashes and controversy
health4 months ago

Vinay Prasad's FDA tenure ends amid data-purity clashes and controversy

A STAT opinion piece assesses Vinay Prasad's tumultuous FDA tenure, noting his push for clearer, stronger data in rare-disease approvals but arguing his impulsive, confrontational approach caused chaos and eroded the agency's credibility; his upcoming departure leaves a controversial legacy about balancing rigorous evidence with regulatory pragmatism.

via statnews.com|
#clinical-data#drug-regulation#fda
FDA Names Biotech Veteran George Tidmarsh as New Top Drug Regulator
health11 months ago

FDA Names Biotech Veteran George Tidmarsh as New Top Drug Regulator

The FDA is set to appoint former biotech executive George Tidmarsh as the new director of the Center for Drug Evaluation and Research, where he will oversee drug approvals and regulation amidst ongoing debates over accelerated approvals and advertising practices, bringing his industry experience to address controversial issues like opioid marketing and drug safety.

via Bloomberg.com|
#biotech#drug-regulation#fda
FDA Warns About Dangerous 'Gas Station Heroin' Substance
health1 year ago

FDA Warns About Dangerous 'Gas Station Heroin' Substance

The FDA has issued a warning about tianeptine, a substance sold as a dietary supplement but known as 'gas station heroin' due to its opioid-like effects and potential for overdose and dependence, despite not being approved in the US. It is often sold online and in shops, with reports of addiction, withdrawal, and overdose cases, raising concerns about its unregulated use and detection challenges.

via ScienceAlert|
#drug-regulation#fda-warning#gas-station-heroin