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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions
… -commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-3 … We’re in an unprecedented era of … further enhancing patient safety and advance a precision medicine approach to the selection of device interventions. … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease
… approval for use in cats, providing access to a novel medicine for our feline companions suffering from … due to CKD,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine. “Additionally, this is the first drug …
FDA issues rule for data collection of antimicrobial sales and distribution by animal species
… including those antibiotics that are not used in human medicine. ADUFA 105 also requires the FDA to prepare summary … M.S., deputy director for science policy in the FDA’s Center for Veterinary Medicine. The final rule also includes a provision …
FDA puts company on notice for marketing unapproved stem cell products for treating serious conditions
… said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Over the past … with the release of the FDA’s comprehensive regenerative medicine policy framework , the FDA is applying a risk-based … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B and Inhibitors
… said Dr. Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to … of Sevenfact was approved by the FDA’s Center for Veterinary Medicine. “Based on a comprehensive analysis of the …
Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development
… tement-fda-commissioner-scott-gottlieb-md-and-director-fdas-center-drug-evaluation-and-research … Protecting patient … older drug that is available as both a generic and brand medicine), there are generally several manufacturers that … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
… $2 million over four years Albert Einstein College of Medicine (Bronx, New York), Caterina Minniti, Phase 2 Study … $1 million over two years Columbia University Medical Center (New York), Elizabeth Shane, Phase 2 Study of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
… Director of the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research. “FDA is … also are involved, including the Alliance for Regenerative Medicine (ARM), Washington, D.C.; the American Society of … 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 formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
… help ensure that patients have continued access to their medicine. They have also asked us for recommendations on the … mitigate shortages. Our drug shortages staff at the FDA’s Center for Drug Evaluation and Research, who are also U.S. … 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 new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
… to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of … This contract is independent from the National Academy of Medicine’s new Action Collaborative on Countering the U.S. … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
… including biologics, medical devices, as well as human and veterinary drugs. Today, I’d like to focus on how we’re … drugs and their use in food-producing animals. The FDA’s Center for Veterinary Medicine (CVM), along with our industry partners and …
FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
… an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online … National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Grants First Full Approval for Treatment of Lymphoma in Dogs
… Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine. “While canine lymphoma affects fewer than 70,000 …
Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
… ess-announcements/statement-janet-woodcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found … … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for … … Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found …
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
… said Steven Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine. “When an animal producer puts animals’ and people’s …
FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
… Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Based on their … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
… Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “The expanded … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. “In addition, prior … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs
… labs will team up with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition to form a … will work closely with the Chief Scientist and Center for Veterinary Medicine (CVM) director to coordinate on research priorities. …
FDA approves novel device for treating breathing difficulty from severe emphysema
… Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health. “This novel … to relieve pressure. The FDA reviewed data from a multi-center study of 190 patients with severe emphysema. In this … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Califf, FDA top officials call for sweeping review of agency opioids policies
… asked the National Academies of Sciences, Engineering, and Medicine to help develop a framework for opioid review, … comprehensive data ever collected in the field of pain medicine and treatments for opioid use disorder. The data … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
… director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “With today’s … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease
… director of the Division of Rheumatology and Transplant Medicine in the 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 Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
… said Charles Ganley, M.D., director of Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. “While there are FDA … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker
… is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with … 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 …