FDA aims to publish a tentative final monograph for OTC sunscreen drugs in 2019 that identifies “data gaps that FDA believes need to be filled” for 16 currently listed UV filters to support their continued marketing in the US without new drug approvals.
The US Sunscreen Innovation Act, signed into law in late 2014, requires FDA to amend and finalize its long-stayed regulations regarding nonprescription sunscreen active ingredients within five years of the SIA’s enactment.
That puts the deadline at Nov. 26, 2019.
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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