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FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “The FDA remains … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
… with specific mutations is a critical part of personalized medicine,” said Eric Bastings, M.D., deputy director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA seeks $5.1 billion total for FY 2017, including funds to implement food safety law, improve medical product safety and quality
… product safety and availability by: evaluating precision medicine tools to “personalize” the diagnosis and treatment … and therapeutics, the FDA will develop a virtual Oncology Center of Excellence to leverage the combined skills of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA expands treatment window for use of clot retrieval devices in certain stroke patients
… director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program
… activities involving human foods. The leadership for Center for Food Safety and Applied Nutrition and Office of … human foods-related activities as well as the Center for Veterinary Medicine activities that have a nexus to human foods. …
FDA approves Mavyret for Hepatitis C
… of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Hepatitis C is a … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments
… said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “There is intense … 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 agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse
… or non-drug treatments, and material on addiction medicine and opioid use disorders. The FDA also developed new … and our laboratories, including our Forensic Chemistry Center. These are important investments to help us identify … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA awards 18 grants to stimulate product development for rare diseases
… 2015 include: Drugs/Biologics: Albert Einstein College of Medicine (Bronx, New York), Deepa Manwani, Phase 2 Study of … $1.6 million over four years University of Kansas Medical Center (Kansas City, Kansas), Mazen Dimachkie, Phase 2 Study … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
… In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This software … in various settings, including primary care, emergency medicine, urgent care and specialty care, such as … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves two hepatitis C drugs for pediatric patients
… of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. Today’s approvals … assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known Risks, Including Heart Rhythm Problems
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves new treatment for adults with partial-onset seizures
… M.D., director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Patients can have … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy
… our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote … said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
… said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA is … with the release of the FDA’s comprehensive regenerative medicine policy framework , including the FDA’s final … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA updates warnings for fluoroquinolone antibiotics
https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics
… of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that … assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first targeted therapy for metastatic bladder cancer
… device. “We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a … 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 Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease
… for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first treatment for frequent urination at night due to overproduction of urine
… of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “It is important to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA permits marketing of first medical device for treatment of ADHD
… director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies
… of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “With today’s … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
… of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. FDA-approved … assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for …
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
… In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This test should … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs
… often have potential side effects, but, unlike in human medicine where patients may be willing to tolerate some … Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “This new medication provides …
FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
… of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “The agency is … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …