SS1 Safety and Efficacy of Diabetes Drugs: Steering between Scylla and Charybdis

Program: Special Scientific Session
Clinical Session
Friday, March 6, 2015: 11:15 AM-12:00 PM
Room 20A (San Diego Convention Center)
**This session is eligible for CME credit**

Janet Woodcock, MD, Food and Drug Administration (FDA), Silver Spring,

Nothing to Disclose: JW

At the FDA, Dr. Woodcock oversees the testing of prescription and over-the-counter drugs to evaluate drug safety and efficacy for consumers. The center also provides information to healthcare professionals and patients, and ensures products meet standards to protect consumers. Dr. Woodcock has led initiatives to modernize drug manufacturing and regulation, and move medical discoveries from the lab to consumers more efficiently. Recently, Dr. Woodcock launched "Safety First" and "Safe Use" initiatives to improve drug safety management inside and out of the FDA, respectively. In this presentation, Dr. Woodcock discusses recent advances and challenges in regulatory requirements for diabetes drugs with a focus on how FDA processes can provide essential safety information without impeding innovation.