Workshop B: FDA 101 For The Life Sciences Products Liability Litigator: Essential Training on Approvals, Labeling, Recalls, and More
What is it about?
Products liability litigation concerning pharmaceutical products and medical devices often hinges on what happened during the FDA pre-approval, approval, or post-approval periods. This comprehensive pre-conference workshop will provide training on critical components of the FDA approval and post-approval periods. From new drug applications to 510Ks to labeling requirements to good manufacturing practices and post approval
concerns related to recalls and withdrawals, this workshop will provide you with the critical FDA regulatory foundation essential to the advancement of your products liability practice.
Points of discussion will include:
- Examining the components of the FDA drug review and approval process that have the greatest impact on products liability cases
- Understanding the pivotal role of the label in matters of preemption and defense strategies
- Exploring the importance of clinical trials and findings
- Comprehending the influence of cGMPs (Current Good Manufacturing Practices) in products liability litigation
- Analyzing how adverse events reports and recalls play into the scope of a products liability action
- Determining premarket approvals
- Exploring the 510(k)-clearance process
12:30 – 2:00
Workshop Luncheon: Available to Participants Attending Both Morning and Afternoon Workshop Sessions