Join us for an afternoon of discussions designed to provide a foundation in FDA, healthcare, and securities issues arising in the development of medical products. Whether you are relatively new to counseling and risk mitigation in these areas or more experienced counsel looking for an efficient way to focus on their application in pre-commercial contexts, this event is for you. Learn from Sidley’s experienced regulatory and disclosure lawyers and get answers to your most pressing questions.
Who Should Attend: Lawyers needing a practical introduction to legal and regulatory issues arising in the development of medical products.
Essential FDA Concepts and Strategic Considerations for Drug Development
- FDA’s expectations of drug developers
- FDA programs to expedite development and regulatory review
- Non-patent exclusivities administered by FDA: considerations for lifecycle management and mitigating litigation risks
- Disputing FDA Actions
- Procedural options and definition of success
- Key factors predicting outcomes
- Appropriate means of influencing FDA
Engagement with Patients and HCPs, Including Compliance Considerations for Pre-Commercial Products
- Obtaining coding, coverage, and reimbursement
- Pricing considerations
- Market access strategies, including expanded/post-trial access
- Arrangements with HCPs and patients
- Right-sized compliance infrastructure
Practical Approaches to SEC, Shareholder Litigation, and FDA Risks in Pre-Approval Communications
- SEC and FDA requirements/coordination with respect to pre-approval communications and disclosures for public life science companies
- Issues and trends in shareholder litigation
- Practical approaches to mitigating regulatory, enforcement, and litigation risks
CLE credit for this program is pending.
For more information, contact Sidley Global Life Sciences.