FDA Bootcamp

Event Description:

Designed specifically to provide you with a clear understanding of this complicated area, a distinguished faculty of top FDA regulatory experts a "Who's Who of the FDA Bar" - will share their knowledge and give you critical insights on:

- The organization, jurisdiction, functions, and operations of the FDA

- The essentials of the approval process for drugs, biologics, and devices, including:

NDAs
INDs
BLAs
OTC approval
510 K submissions
PMA process

- Clinical trials for drugs and biologics and the clearance process for devices

- The classification of devices and the concept of "risk-based" classification

- The role of the Hatch-Waxman Act in the patenting of drugs and biologics

- Labeling in the drug and biological products approval process

- cGMPs and other manufacturing concerns relative to products liability

- Proactive adverse events monitoring

- Recalls, product withdrawals, and FDA oversight authority

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