University of Kentucky Office of Research Integrity D116.0000 . Food and Drug Administration (FDA) Resources. 3 . Biologic • What is a biologic product? https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers •

The ORI FDA Research Question and Answer website provides training materials, interactive tools, resources, and information on multiple areas of FDA-regulated research including research testing drugs, devices, software as medical device, and treatments including emergency use, expanded access, and Humanitarian Use Devices.

FDA Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency CDER is committed to supporting the development of novel drugs, and the potential repurposing of existing therapies, to address the Coronavirus Disease 2019 (COVID-19) …

AppalTRuST is funded over five years with a $19 million grant from the National Institute on Drug Abuse (NIDA) under the National Institutes of Health (NIH), the Office of the Director of the NIH and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

On July 6, 2023, the U.S. Food and Drug Administration (FDA) granted full approval to lecanemab, marketed as Leqembi, for the treatment of Alzheimer’s disease. The University of Kentucky’s Sanders-Brown Center on Aging has been working with this drug and others like it for more than a decade.

Apr 12, 2023 · Dr. Slavova has been the principal investigator on grants funded by the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice, the Centers for Disease Control and Prevention (CDC), the National Highway Traffic Safety Administration (NHTSA), and the National Institute on Drug Abuse (NIDA).

Aug 1, 2021 · The University of Kentucky Division of Regulatory Services (UKDRS) continued development of a risk-based Animal Feed Inspection Program. Harrison, G. & Johnson, D. Food and Drug Administration. 7/1/21 → 6/30/23. Project: Research project

Oct 1, 2020 · A drug quality study conducted at the University of Kentucky found impurities and lower than acceptable levels of the active pharmaceutical ingredient in some samples of a commonly used injectable drug. As a result, UK filed a petition with the Food and Drug Administration (FDA) to recall identified lots of the medication.

From navigating funding opportunities and ensuring compliance with regulations, to offering guidance on research strategies and operational support, we are here to streamline processes and help turn ideas into impactful solutions.

Jul 18, 2011 · The University of Kentucky Food Systems Innovation Center will conduct a Better Process Control School July 28-29 in Lexington. This is the first time this Food and Drug Administration-approved course has been offered in Kentucky.