FDA seeks permanent injunctions against two stem cell clinics
FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval
Archive for the ‘Drug Recalls & Safety Notices’ category
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling
FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
FDA approves Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer
FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget
FDA Commissioner Scott Gottlieb, M.D. remarks to a U.S. Senate Subcommittee on Appropriations on the FDA’s Fiscal Year 2019 budget
Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes
FDA announces several new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes.
FDA authorizes new use of test, first to identify the emerging pathogen Candida auris
FDA authorized the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
FDA announces new steps to encourage more widespread innovation and development of new treatments for opioid use disorder
FDA takes new steps to advance the development of innovative products for treating opioid use disorder
FDA announces new steps to encourage and support the development of treatment options for people with opioid use disorder
Federal judge enters consent decree against Cantrell Drug Company
Cantrell Drug Company prohibited from manufacturing and distributing sterile drug products in violation of the law
Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA
FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget
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.