Food and Drug Administration

Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices

Do, 16/06/2019 - 18:31
Federal officials seize adulterated dietary supplements from Life Rising Corporation due to poor manufacturing practices
Categorie: Istituzioni

Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys

Do, 16/06/2019 - 18:31
FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys
Categorie: Istituzioni

FDA finalizes guidance for premarket tobacco product applications for electronic nicotine delivery systems as part of commitment to continuing a strong oversight of e-cigarettes

Do, 16/06/2019 - 18:31
FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”
Categorie: Istituzioni

FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Do, 16/06/2019 - 18:31
FDA approved Polivy in combination with the chemotherapy bendamustine and a rituximab product to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
Categorie: Istituzioni

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

Do, 16/06/2019 - 18:31
FDA permits marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS.
Categorie: Istituzioni

Remarks on World Food Safety Day: ‘Food Safety Is Everyone’s Business’

Do, 16/06/2019 - 18:31
Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day
Categorie: Istituzioni

FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf

Do, 16/06/2019 - 18:31
FDA and FTC cite four firms that make or sell several flavored e-liquid products for violations related to online posts by social media influencers on each company’s behalf.
Categorie: Istituzioni

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

Do, 16/06/2019 - 18:31
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
Categorie: Istituzioni

FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

Do, 16/06/2019 - 18:31
FDA approves new use of Emgality to treat episodic cluster headache
Categorie: Istituzioni

Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law

Do, 16/06/2019 - 18:31
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
Categorie: Istituzioni

FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer

Do, 16/06/2019 - 18:31
The FDA Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.
Categorie: Istituzioni

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

Do, 16/06/2019 - 18:31
FDA today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.
Categorie: Istituzioni

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine

Do, 16/06/2019 - 18:31
Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine
Categorie: Istituzioni

FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions

Do, 16/06/2019 - 18:31
FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions
Categorie: Istituzioni

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

Do, 16/06/2019 - 18:31
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

Do, 16/06/2019 - 18:31
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 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

Do, 16/06/2019 - 18:31
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

Do, 16/06/2019 - 18:31
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 Statement on the FDA’s ongoing investigation into valsartan and ARB class impurities and the agency’s steps to address the root causes of the safety issues

Do, 16/06/2019 - 18:31
FDA describes the ongoing investigation into the ARB class impurities and agency’s steps to address the root causes of the safety issues
Categorie: Istituzioni