FDA warns BioLyte Laboratories and Honest Globe about making OTC drugs with cannabinoids. Firms also advised about GMP problems and that labeling cannabinoids as inactive ingredients doesn’t make their use compliant.
Consumer health products containing cannabinoids and deemed unapproved drugs in the US aren’t limited to products marketed as dietary supplements. The Food and Drug Administration has warned a contract manufacturer and another firm about making OTC drugs with cannabinoids.
The firms, BioLyte Laboratories LLC and Honest Globe Inc., also were advised by the FDA’s Office of Regulatory Affairs Division...
Devices authorized for marketing outside the US. Data derived from Citeline’s Meddevicetracker. Updated weekly.
PATIENT ACCESS TO UNAPPROVED MEDICAL PRODUCTS WOULD BE ALLOWED under legislation introduced by Rep. Peter DeFazio (D-Ore.) on July 12 and Sen. Tom Daschle (D-S.D.) on July 14. Called the Access to Medical Treatment Act, the legislation would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements to patients as long as there is no evidence the treatment causes harm and the patient is informed about the treatment and its possible side effects. DeFazio's bill is identified as HR 2019; Daschle's version will be assigned a bill number the week of July 17.
A look at new research on the cardiovascular effects of ADHD medications and what it means for clinical care. This article explores the latest clinical and epidemiological research on the cardiovascular effects of medications commonly prescribed for ADHD, examining potential heart-related risks, underlying mechanisms, and their implications for patient safety, clinical decision-making, and long-term treatment strategies across diverse age groups and risk profiles.
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