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FDA and NRC pave way for the first domestic supply of the most commonly used medical isotope in diagnostic imaging
… Tc-99m,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This radioisotope … access to this important imaging agent used in nuclear medicine.” Tc-99m has been in use as a medical imaging … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA grants accelerated approval to new treatment for advanced ovarian cancer
… Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director … CDxBRCA companion diagnostic is marketed by Foundation Medicine, Inc. of Cambridge, Massachusetts. The FDA, an … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first PI3K inhibitor for breast cancer
… said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For this approval, … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first oral GLP-1 treatment for type 2 diabetes
… of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this … that Rybelsus is not recommended as the first choice of medicine for treating diabetes. Patients who have ever had … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA permits marketing of mobile medical application for substance use disorder
… director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “Mirabegron, the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Takes Action to Restrict Unlawful Import of Xylazine
… xylazine into the country are intended for the legitimate veterinary supply, including active pharmaceutical … use only,” said Tracey Forfa, J.D., director of the FDA’s Center for Veterinary Medicine. The FDA and its Office of Criminal Investigations …
FDA Fast Facts: FDA’s Support of the Hurricane Relief Effort
… the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations
… for the first time. Beginning in the next few months, our Center for Drug Evaluation and Research (CDER) will adopt new … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion
… therapies continue to advance the practice of medicine at a rapid pace and offer options to patients who … said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel
… program to ensure delivery of critical battlefield medicine to our service members downrange." The FDA outlined … phase of the program will be conducted among the FDA’s Center for Biologics Evaluation and Research (CBER) and … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia
… Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s approval … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first generics of Eliquis
… said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These approvals … Please contact the manufacturers for information about the medicine’s availability. The FDA, an agency within the U.S. … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first generics of Gilenya
… the FDA,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Having access to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
… 3D printing facilities located on the FDA’s campus. The Center for Drug Evaluation and Research’s (CDER) facility … the recently released regulatory framework on regenerative medicine medical products .The Center for Biologics … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: Daily Roundup May 7, 2020
… (FNLCR), a Federally Funded Research and Development Center sponsored by the National Institutes of Health’s (NIH) … the Mount Sinai Health System, the Icahn School of Medicine at Mount Sinai, including members of the Departments … guidance also includes examples of steps FDA’s Center for Veterinary Medicine may take to prevent or mitigate animal …
FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
… an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online … and Office of Enforcement and Import Operations, and the Center for Drug Evaluation and Research. The operation is a … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
… require evidence from premarket clinical trials that the medicine will be both effective and safe for use when … Backlog of PMRs/PMCs . The report highlighted that the FDA Center for Drug Evaluation and Research (CDER) completed … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Intratumoral Injection to Treat Non-Metastatic Mast Cell Tumors in Dogs
… Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This approval provides an additional treatment …
FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
… term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Patient safety … American Urogynecologic Society, the National Library of Medicine and others on this effort, known as the Women’s … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA takes action against Florida medicated animal feed manufacturer
… said Steven Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine. “The FDA will take whatever steps are necessary to …
FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
… acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. A stroke occurs … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
… drivers of a disease, have the potential to transform medicine, so we can better confront and even cure … of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. The efficacy of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
… the continued momentum of this promising new area of medicine and we’re committed to supporting and helping … said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). The … the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for …
Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk
… /statement-fda-commissioner-scott-gottlieb-md-and-biologics-center-director-peter-marks-md-phd-fdas … Stem cell therapies … are one of the most promising new fields of science and medicine. These products hold tremendous potential for … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …