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FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
… Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and … an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities
… and efficient way. Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office … an overall stronger agency. While the FDA’s Center for Veterinary Medicine (CVM) will continue to operate as a stand-alone …
Coronavirus (COVID-19) Update: Daily Roundup June 4, 2020
… can visit BeSafeRx to learn about how to safely buy medicine online. Today, the FDA announced that on Tuesday, … at the FDA; Jeffrey E. Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) at the FDA; … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
… said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Scientific … include breakthrough therapy designation, regenerative medicine advanced therapy designation, and fast track … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
… guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D. … 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 …
Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice
… made up of senior leaders and risk managers in the FDA’s Center for Food Safety and Applied Nutrition with experience in toxicology, chemistry, medicine, epidemiology, policy and law. The Government … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020
… the FDA and the FTC jointly issued a warning letter to the Center for Wellness and Integrative Medicine for selling unapproved and unauthorized products to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: Daily Roundup July 27, 2020
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease
… of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. Congenital heart … TPV device through a prospective, non-randomized, multi-center clinical study. During the study, physicians implanted … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approval brings first gene therapy to the United States
… and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to … T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new … the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for …
FDA Launches New Era of Smarter Food Safety Initiative, Releases Blueprint and Pilot Study
… Food Policy and Response, Susan Mayne, the director of our Center for Food Safety and Applied Nutrition, Steve Solomon, the director of our Center for Veterinary Medicine, and Judy McMeekin, the Associate Commissioner for …
FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium
… 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 agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
… a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified … closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first generic naloxone nasal spray to treat opioid overdose
… overdose death,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “All together, these … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: Daily Roundup April 10, 2020
… COVID-19 Response by Mitch Zeller, director of the FDA’s Center for Tobacco Products, was issued. It provides a … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities
… with the National Academy of Science, Engineering, and Medicine (NASEM) and through the FDA's Centers of Excellence … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis
… to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of such … mail-back pouches) to help get unused medications out of medicine cabinets. The FDA is actively revising our … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
… already trained more than 90 percent of its staff in the center for devices on these requirements. We plan to complete … of these new modalities like gene therapy and regenerative medicine, where there’s so much uncertainty, we encourage … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts
… acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. Traumatic brain … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: Daily Roundup April 17, 2020
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Roundup: December 22, 2023
… guidances published this week. On Thursday, the FDA’s Center for Veterinary Medicine announced final Guidance for Industry #61, entitled …
FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients
… J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “While the FDA has … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
… said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Patients with … the continued momentum of this promising new area of medicine and the FDA’s commitment to supporting and helping … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Statement on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings
… Prinston Pharmaceuticals Inc., contacted the FDA‘s Center for Drug Evaluation and Research (CDER) about its … for potential changes in the recall status of their medicine. We are continuing to update this information on a … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign
… in a National Academies of Sciences, Engineering, and Medicine report in 2018 on the Public Health Consequences of … agencies, and others, which are available through the Center for Tobacco Products’ Exchange Lab . In addition to … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …