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FDA Insight: Anti-Microbial Resistance
… Dr. Shah welcomes Dr. Steve Solomon, Director of FDA's Center for Veterinary Medicine, to discuss the work CVM is doing in combating …
Reauthorization of the Animal Drug User Fee Programs - 03/30/2023
… of the Subcommittee. I am Tracey Forfa, Director of the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA or …
Improving Animal Health: Reauthorization of FDA Animal Drug User Fees - 02/12/2018
… … Statement of Steven Solomon, D.V.M., Mph Director, Center for Veterinary Medicine, FDA Before the Committee on Health, Education, …
FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns
… … Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its …
FDA In Brief: FDA issues draft guidance to voluntarily bring remaining approved over-the-counter medically important antimicrobial drugs for animals under veterinary oversight
… Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “Once the final version of this guidance is …
FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda
… -announcements/fda-supports-innovation-animal-biotechnology-veterinary-products-food-animals-through-new … Today, the … and details the supporting actions by the agency’s Center for Veterinary Medicine (CVM) to foster product development and implement …
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
… ress-announcements/statement-douglas-throckmorton-md-deputy-center-director-regulatory-programs-fdas-center-drug … Among the biggest challenges health care … 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 FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
… Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, … resistance. As part of the FDA’s regulatory mission, our Center for Veterinary Medicine (CVM) is responsible for …
FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence
… today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to enhance … face,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA looks … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from Stephen Ostroff M.D., Deputy Commissioner for Foods and Veterinary Medicine, on National Toxicology Program draft report on Bisphenol A
… /statement-stephen-ostroff-md-deputy-commissioner-foods-and-veterinary-medicine-national-toxicology … One of the U.S. Food and Drug … was conducted by senior scientists at the FDA’s National Center for Toxicological Research (NCTR). The study is part …
FDA requires stronger warnings about rare but serious incidents related to certain prescription insomnia medicines
… public,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We’ll continue to … with a patient medication guide that explains the medicine’s uses and risks. Patients should review this … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Advancing the Development of Innovative Veterinary Products
… /news-events/fda-voices/advancing-development-innovative-veterinary-products … By: Steven M. Solomon, D.V.M., M.P.H., Director, Center for Veterinary Medicine The U.S. Food and Drug Administration’s Center for …
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
… … Español In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration … said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Precision care … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids
… ress-announcements/statement-douglas-throckmorton-md-deputy-center-director-regulatory-programs-fdas-center-drug-0 … As … with the National Academies of Sciences, Engineering, and Medicine to help advance the development of evidence-based … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers
… -announcements/fda-statement-douglas-throckmorton-md-deputy-center-director-regulatory-programs-center-drug … Español The … these medicines also include codeine. In all cases, if the medicine contains codeine or tramadol, parents should consult … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
… /statement-fda-commissioner-scott-gottlieb-md-director-fdas-center-drug-evaluation-and-research-janet … For more than 30 … even in circumstances where the availability of a medicine through EA would appropriately balance these … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products
… ner-scott-gottlieb-md-and-fda-deputy-commissioner-foods-and-veterinary … Beginning in February of this year, numerous … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for … M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of …
FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products
… -extends-enforcement-discretion-policy-certain-regenerative-medicine-products … Today, the U.S. Food and Drug … said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). Since … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
… is a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products
… … Veterinary regenerative medicine is a rapidly growing area of product development … (e.g., improving animal fertility) of animals. The FDA’s Center for Veterinary Medicine provides regulatory oversight …
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
… ents/press-announcements/jeffrey-shuren-md-jd-director-fdas-center-devices-and-radiological-health-and-janet-woodcock-md … rapidly advancing, and very promising, area of science and medicine is the field of genetic tests. Genetic testing can … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
… the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for … M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed …
FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
… medicines should continue taking their medicine until they have a replacement product. To determine … said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. The FDA will … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad
… tement-fda-commissioner-scott-gottlieb-md-and-director-fdas-center-drug-evaluation-and-research-0 … At the FDA, … and, when appropriate, may require changes in how a medicine (both brand-name and generic versions) is used or … the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for …
FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX
… Criminal Investigations, Office of Regulatory Affairs, and Center for Drug Evaluation and Research participated in the … 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 …