Istituzioni

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management
Categorie: Istituzioni

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

The FDA approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in

FDA issues statement on agency’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
Categorie: Istituzioni

FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.
Categorie: Istituzioni

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market

FDA announces final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.
Categorie: Istituzioni

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility.
Categorie: Istituzioni

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in p

The FDA is issuing two draft guidances, which, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information in drugs used during pregnancy or lactation.
Categorie: Istituzioni

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
Categorie: Istituzioni

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
Categorie: Istituzioni

FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids

Agency issued two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products

FDA is announcing a number of important new steps and actions to advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.
Categorie: Istituzioni

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
Categorie: Istituzioni

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of brea

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants
Categorie: Istituzioni

First FDA-approved vaccine for the prevention of dengue disease in endemic regions

FDA approves first vaccine for prevention of dengue disease in people ages 9-16 who have laboratory-confirmed previous dengue infection and live in endemic areas, such as the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
Categorie: Istituzioni

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines

FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines - eszopiclone, zaleplon and zolpidem
Categorie: Istituzioni

FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers
Categorie: Istituzioni

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.
Categorie: Istituzioni
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