Food and Drug Administration

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Press releases from FDA
Aggiornato: 4 ore 3 min fa

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

Ve, 16/02/2018 - 22:48
FDA approves drug to reduce the risk of stage III non-small cell lung cancer progressing
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine

Gi, 15/02/2018 - 22:20
FDA provides update on flu vaccines during this severe flu season
Categorie: Istituzioni

FDA expands treatment window for use of clot retrieval devices in certain stroke patients

Gi, 15/02/2018 - 18:20
FDA expands treatment window for use of clot retrieval devices in certain stroke patient
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs

Gi, 15/02/2018 - 15:31
FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease
Categorie: Istituzioni

FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint

Me, 14/02/2018 - 19:46
FDA approves Erleada (apalutamide), first treatment for non-metastatic, castration-resistant prostate cancer
Categorie: Istituzioni

FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults

Me, 14/02/2018 - 19:21
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults; new quick testing option to help reduce need for CT scans, radiation exposure for patients
Categorie: Istituzioni

FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

Ma, 13/02/2018 - 21:58
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition

Ma, 13/02/2018 - 21:33
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

Gi, 08/02/2018 - 17:43
FDA announces on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.
Categorie: Istituzioni

FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging

Gi, 08/02/2018 - 17:26
FDA and NRC today took important steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Ma, 06/02/2018 - 20:06
FDA statement on scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
Categorie: Istituzioni

Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure

Ve, 02/02/2018 - 19:11
One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on a myriad scientific evidence developed over many years to help inform our regulatory thinking. Although the Federal Communications Commission (FCC) sets the standard for radiofrequency energy exposure limits from cell phones, the FCC relies on the FDA and other health agencies for scientific expertise and input regarding those standards.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season

Gi, 01/02/2018 - 21:18
FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

Ma, 30/01/2018 - 16:34
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Categorie: Istituzioni

FDA, USDA announce formal agreement to bolster coordination and collaboration

Ma, 30/01/2018 - 15:38
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
Categorie: Istituzioni

FDA approves new treatment for certain digestive tract cancers

Ve, 26/01/2018 - 17:55
FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study

Ve, 26/01/2018 - 16:21
FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study
Categorie: Istituzioni

FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims

Me, 24/01/2018 - 16:28
FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy steps for strengthening public warning and notification of recalls

Gi, 18/01/2018 - 21:16
FDA discusses new policy steps for strengthening public warning and notification of recalls
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Ma, 16/01/2018 - 20:36
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Categorie: Istituzioni