FDA: Drug, Device and Biologic Regulatory Issues

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Saturday, June 4 | 4:30 PM - 6:00 PM
Room 214A

Upon completion of this activity, the participant will be able to:
1. Describe device, drug and biologic regulations.
2. Appropriately charge for a device, drug or biologic in a clinical trial.
3. Explain what the FDA is doing in regard to radiation safety initiatives.
4. Describe the recent changes to PET drug regulations. 

Speakers are:
Phillip Davis, MD, of the FDA;
Simkeon A. Kang, MD, of the FDA;
Lucie L. Yang, MD, PhD, of the FDA;
Joseph M. Kaminski, MD, of the FDA; and
Dwaine Rieves, MD, director of the medical imaging products division at the FDA's Center for Drug Evaluation and Research.