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Press releases from FDA
Updated: 2 hours 44 min ago

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

Thu, 2018-02-15 08:31
FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease

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

Wed, 2018-02-14 12:46
FDA approves Erleada (apalutamide), first treatment for non-metastatic, castration-resistant prostate cancer

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

Wed, 2018-02-14 12:21
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

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

Tue, 2018-02-13 14:58
FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients

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

Tue, 2018-02-13 14:33
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

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.

Thu, 2018-02-08 10:43
FDA announces on groundbreaking approval and interagency approach to bring stable supply of critical medical imaging isotope to the U.S.

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

Thu, 2018-02-08 10:26
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

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

Tue, 2018-02-06 13:06
FDA statement on scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

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

Fri, 2018-02-02 12:11
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.

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

Thu, 2018-02-01 14:18
FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season

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

Tue, 2018-01-30 09:34
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

FDA, USDA announce formal agreement to bolster coordination and collaboration

Tue, 2018-01-30 08:38
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.

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