FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget
Category Archives: Drug Safety Information Podcasts
FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.
Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice
One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation
The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices
La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura
: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.
FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
FDA permits marketing of first medical device to use artificial intelligence to detect greater than a mild level of diabetic retinopathy in the eye of adults who have diabetes.
FDA clears first contact lens with light-adaptive technology
FDA clears first contact lens with additive that automatically darkens the lens when exposed to bright light
FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information
FDA is restricting the sale and distribution of the Essure device to only those health care providers who provide information to women about the risks and benefits of this device before they get the permanent contraception implant.