PPT-United States Food and Drug Administration (FDA)

Office of Regulatory Affairs ORA A Brief Web Demonstration of FDA Free Online Resources for Industry By John T Sproul PhD Consumer Safety Officer International and Federal Engagement Division of Integration. Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Health. , . Law. . and. . Bioethics. . 2014. By. : Ana Granadeiro. 1. background . The . release of thalidomide in the 1950s and 1960s led to the world’s most . publicised. pharmaceutical disaster.. James C. Shehan. Hyman, Phelps & McNamara, P.C.. 700 Thirteenth Street, N.W., Suite 1200. Washington, D.C. 20005, U.S.A.. 202-737-9634 .  . jshehan@hpm.com. October 29, 2014. Agenda. BPCIA Overview. and the Law. Chapter 3. Guidelines for Controlling Drug Development and Marketing. Society has the right to protect itself from the damaging impact of drug use.. Society has the right to demand safe and effective drugs.. Quinine is FDA-approved for the treatment of uncomplicated malaria. It is not considered safe and ef-fective for the treatment or prevention of leg cramps-- an use. Quinine is associated with thrombo Routes of administration. Chapter Topics. Routes of administration. Oral route of administration. Transmucosal. route of administration. Topical route of administration. Inhalation route of administration. David W Feigal, Jr MD MPH. Adjunct Professor, O’Connor College of Law, ASU. January 16, 2016. Workshop: . Pharmaceutical Pricing and Marketing: Markets versus Regulation. “When I use a word” Humpty Dumpty said in a rather scornful tone, “it means just what I chose it to mean – neither more nor less.”. By: Kaytlynn Martin Period 6. . Also known as: FFDCA. Draft Year: 1938. Amendment Years: 1954 and 1958 . This is a a . National . legislation (U.S). The FFDCA is a set of laws passed by congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics . Investigational New Drug Application (IND); Summary of regulations and guidelines . Introduction of . cGMP's. /principles of validation . Introduction to QA/QC principles . Good Laboratory Practice (GLP) compliance . precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. patent brand-name medicines. Low-cost generic drugs—Food and Drug Administration (FDA)-approved, interchangeable versions of the same products made by different manufacturers—were considered II. FDA's Authority FDA has broad authority. 2 It is the sole United States regulatory body for pharmaceuticals for human use and for medical devices. products are located somewhere other than th 9/21 Page 1 Commissioner : J anet Woodcock, M.D. Department: Department of Health and Human Services (HHS) History & Mission: The Food and Drug Administration dates its origin to June 1906, when Pre 2022 Update. COSDA Annual Conference. October 2, 2022. Siobhan DeLancey, RVT, MPH. Senior Advisor for Strategic Communications. www.fda.gov. One Health - Related Actions. Issued four Warning Letters .