FDA: Drug, Device and Biologic Regulatory Issues
Saturday, June 4 | 4:30 PM - 6:00 PM
Room 214A
Objectives
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.
Room 214A
Objectives
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.