FDA regulation

FDA moves to regulate medicines produced in bulkThe U.S. Food and Drug Administration issued a draft guidance in March proposing to regulate medicines that are produced in bulk by compounding pharmacies.
Opposition to looming compounding practice changesIn this article, Dr. Murad Alam, M.D., president elect of the American Society for Dermatologic Surgery, addresses how changes in federal and state regulations that govern compounding medications could impact physicians and patients.
Could Compounding Pharmacists Solve the Sodium Bicarbonate Shortage?
Could Compounding Pharmacists Solve the Sodium Bicarbonate Shortage?As stocks of the vital drug become rarer, pharmacists could be the ones combatting the shortage.
The Top Six Ways Trump’s Policies Will Impact Pharmacies
The Top Six Ways Trump’s Policies Will Impact PharmaciesHow the new Trump administration will affect everything from the ACA to the FDA.
Changing FDA regs impact dermatologists, patientsRecent actions around drug compounding, sunscreen ingredient approvals, drugs and medical devices, cosmetic product marketing and more will affect your practice. Stay informed.
Tech innovation: how to turn your idea into a marketable medical deviceFinancial sustainability, intellectual property rights, and protection of the idea are all considerations for physician inventors who want to create new medical devices.
Pediatric trials for AD systemic treatmentsAt a recent meeting, the Food and Drug Administration Dermatologic and Ophthalmic Drugs Advisory Committee supported early clinical development of systemic products for pediatric patients with atopic dermatitis that has been inadequately responsive to topical therapies.
CEO resignation linked to FDA drug approval processSarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.
Are teen users of electronic cigarettes at increased risk for substance use?Teenagers who smoke the popular electronic cigarettes (e-cigarettes) are less likely to use substances than adolescents who use both cigarettes and e-cigarettes (dual users) but more likely to use them than teenagers who have never used either product (nonusers).
Eye donation by gay teen that committed suicide rejectedA gay teen that committed suicide after being bullied by his classmates had one last wish—to donate his organs. While his kidneys, liver, heart, and lungs were donated, because of an FDA regulation, his eyes were not due to his sexual orientation.