FDA’s 5 guidance documents provide details for drug development for neurological conditions such as ALS and Alzheimer’s disease
Category Archives: Drug Safety Information Podcasts
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
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
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
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
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.
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
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
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
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
FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season