Istituzioni

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

Food and Drug Administration - Me, 26/06/2019 - 22:41
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 approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

Food and Drug Administration - Ma, 25/06/2019 - 22:11
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

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

Food and Drug Administration - Lu, 24/06/2019 - 21:47
FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
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

Food and Drug Administration - Lu, 24/06/2019 - 21:47
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

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management

Food and Drug Administration - Ve, 21/06/2019 - 20:30
FDA Warns Against the Use of Unauthorized Devices for Diabetes Management
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 20/06/2019 - 19:52
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

Food and Drug Administration - Gi, 20/06/2019 - 19:52
FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions
Categorie: Istituzioni

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

Food and Drug Administration - Me, 19/06/2019 - 19:33
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

Food and Drug Administration - Ma, 18/06/2019 - 19:15
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

Food and Drug Administration - Lu, 17/06/2019 - 18:47
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

Food and Drug Administration - Lu, 17/06/2019 - 18:47
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 FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Food and Drug Administration - Sa, 15/06/2019 - 17:31
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.
Categorie: Istituzioni

FDA approves first PI3K inhibitor for breast cancer

Food and Drug Administration - Sa, 15/06/2019 - 17:31
FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.
Categorie: Istituzioni

FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality

Food and Drug Administration - Ve, 14/06/2019 - 17:00
FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
Categorie: Istituzioni

FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

Food and Drug Administration - Ma, 11/06/2019 - 15:36
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
Categorie: Istituzioni

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Food and Drug Administration - Ma, 11/06/2019 - 15:36
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
Categorie: Istituzioni

FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

Food and Drug Administration - Lu, 10/06/2019 - 14:45
FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results
Categorie: Istituzioni

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

Food and Drug Administration - Ve, 07/06/2019 - 13:26
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
Categorie: Istituzioni

Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities

Food and Drug Administration - Ve, 07/06/2019 - 13:26
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Illinois.
Categorie: Istituzioni

Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

Food and Drug Administration - Ve, 07/06/2019 - 13:26
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Categorie: Istituzioni
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