Istituzioni

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

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

FDA finalizes guidance for manufacturers submitting premarket tobacco product applications for electronic nicotine delivery systems, such as e-cigarettes or “vapes.”

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.

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.

Remarks from Deputy Commissioner Frank Yiannas on World Food Safety Day

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.

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

FDA approves new use of Emgality to treat episodic cluster headache

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

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.

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.

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

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

FDA is soliciting feedback on the potential use of new authorities under the SUPPORT Act to require certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.

FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

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.

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

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.