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FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer
… said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of … the F1CDx companion diagnostic was granted to Foundation Medicine, Inc. The FDA, an agency within the U.S. Department … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
… fields of science, we stand at an inflection point in medicine – where new technology is creating foundational … saw many breakthrough drugs result. A whole new field of medicine grew up very fast. I believe we’re at a similar … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
… M.D., acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research. “With this first … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food
… levels,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “Experts at the Institute of Medicine have concluded that reducing sodium intake to 2,300 … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
… false promise that they will respond well to a certain medicine or keeping them from using therapies that may … them,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We are issuing … 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 balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
… this same aggressive approach to changing the culture of medicine around treating pain. The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA orders important safety labeling changes for Addyi
… director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research’s Office of New … 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 new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal
… as a child accidentally ingesting pills they found in a medicine cabinet. There are also technologies that could … in a workshop convened by the Duke-Margolis Center for Health Policy that generated additional ideas for … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
… Office of Hematology and Oncology 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 New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
… said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Gene and cell … The FDA granted Breyanzi Orphan Drug , Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
… to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more … development of products as the FDA Commissioner and Center for Biologics Evaluation and Research director … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic
… of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Controlled clinical … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
… -director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug … Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. … the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
… is typically managed by substitution of another opioid medicine, followed by gradual reduction or transition to … Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research. Lucemyra is an oral, … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Clarifies Approach to Genomic Alterations in Animals
… and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, … of the science,” said Tracey Forfa, director of the FDA’s Center for Veterinary Medicine. “These updated guidance documents demonstrate our …
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
… Ph.D., director of the Office 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 …
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. bl
… challenges and harness the full potential of precision medicine and digital technologies to improve health and … dark web. Our budget request helps increase our field and center operational capacity to enable review of up to 100,000 … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death
… opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. “Today, we have … 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 Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
… of Compounded Products The FDA proposes the creation of a “Center of Excellence on Compounding for Outsourcing … would represent a largely domestic industry. The Center of Excellence would identify and propose solutions to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients
… Maryland and Johns Hopkins University, two of the agency’s Center of Excellence in Regulatory Science and Innovation … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL
… using a scientific advance in this promising new area of medicine,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We’re seeing … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves Vosevi 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 …
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
… moving toward a more team-based approach as part of our Center for Drug Evaluation and Research’s (CDER) Office of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Conditionally Approves First Oral Tablet to Treat Lymphoma in Dogs
… Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “We are encouraged to see drug companies bring …
FDA approves first treatment for all genotypes of hepatitis C in pediatric patients
… of the Division of Antiviral Products 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 …