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FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
… of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “This approval … prevention method in which people who do not have HIV take medicine on a daily basis to reduce their risk of getting HIV … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA unveils plan to eliminate orphan designation backlog
… 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 efforts to strengthen FDA’s expanded access program
… Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA seeks permanent injunctions against two stem cell clinics
… practice requirements. “Cell-based regenerative medicine holds significant medical opportunity, but we’ve … injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
… 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. “Clinical trials … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products
… Ensuring Community and National Resilience in COVID-19 . Veterinary Medicine Our Center for Veterinary Medicine is working with veterinary …
FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury
… director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. ImPACT software … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA allows marketing of clot retrieval devices to reduce disability in stroke patients
… director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Now health care … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis
… said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This challenge led us to using an alternative approach based on precision medicine, which made it possible to identify certain gene … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit
… said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “As part of the … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA takes important step to increase the development of, and access to, abuse-deterrent opioids
… M.D., deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “It is essential … 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’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
… costs and broaden patient access. Thus far this year, our Center for Drug Evaluation and Research has already approved … and patients to get better information about how a new medicine works—is by developing the science around innovative … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Criminal and civil actions filed against Aegerion Pharmaceuticals Inc.
… with the law, subject to judicial oversight. The FDA’s Center for Drug Evaluation and Research was instrumental in … more closely manage a drug’s risks when we don’t believe a medicine’s benefits would outweigh its side effects without … assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for …
FDA approves first MRI-guided focused ultrasound device to treat essential tremor
… director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health. “As with other … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Roundup: November 21, 2023
… of SoClean2 or SoClean3 equipment. Today, the FDA issued a Center for Drug Evaluation and Research (CDER) alert warning … in occlusion alarms. On Monday, the FDA’s Center for Veterinary Medicine published a Perspectives with CVM blog post, CVM …
Federal court issues decision holding that US Stem Cell clinics and owner adulterated and misbranded stem cell products in violation of the law
… from a patient’s adipose tissue. “Cell-based regenerative medicine holds significant medical opportunity, but those in … said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We are … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA issues third status report on investigation into potential connection between certain diets and cases of canine heart disease
… Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “Our ongoing work in this area is a top priority …
FDA Permits Marketing of New Device Designed to Reduce Sleep Disturbance Related to Nightmares in Certain Adults
… Ph.D., director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. PTSD is a … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
… review. On the prescription drugs and biologics side, our Center for Drug Evaluation and Research and our Center for … and generic animal drug user fee programs, our Center for Veterinary Medicine continues to meet all of its user fee-related …
FDA Authorizes Marketing of Device to Improve Gait in Multiple Sclerosis Patients
… acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. MS is a chronic, … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
… do. That’s why we encourage sponsors to participate in our Veterinary Innovation Program , which facilitates … to Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine. “Today, the journal Nature Biotechnology published …
Coronavirus (COVID-19) Update: Daily Roundup May 4, 2020
… can visit BeSafeRx to learn about how to safely buy medicine online. The FDA authorized the first serology, or … (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Institutes of … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Grants First Conditional Approval Under Expanded Authority to Control Seizures in Dogs with Idiopathic Epilepsy
… literature review in 2012 in the Journal of the American Veterinary Medical Association . “We are pleased to see … Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “We are especially encouraged that the sponsor …
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
… (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen … said Janet Woodcock, M.D., director of 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 …