Ocean Township, N.J.-based Flawless Beauty has been on FDA's radar since 2013, targeted with two facility inspections and a previous complaint that triggered product seizures by US Marshals. Unapproved skin-whitening injectables sold by the company pose potential serious health risks, according to a New Jersey District Court consent decree of permanent injunction against the company and its owners.
Serial FDA offender Flawless Beauty LLC and affiliate RDG Imports LLC must cease sales of unapproved drugs and recall a number of injectable skin-whitening products under a consent decree entered by New Jersey District Court Sept. 26.
The US Department of Justice filed suit against the New Jersey-based companies, along with co-owners Jack Gindi and Susana Boleche,...
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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