Charging for Investigational Drugs: Current Application of 21 CFR Part 312 and the Expanded Access Rules 2013

Topics

• Differences between indirect and direct costs and how these are viewed in terms of charging for the drug
• FDA’s rationale for the expansion, so that a lot of these tricky requirements make more sense
• Rules for charging for the sponsor’s own drug vs. charging for an approved drug obtained from another entity for use as an active control
• Time limits, population size limits, requirements for progress of the clinical trial
• Supporting document requirements with some examples
• Review the guidelines and provide some practical advice for moving forward in each of these areas
• Promotion limitations, liability, interim labeling and overall economic impacts that FDA will consider before final authorization
• Price setting followed by some advice on how to navigate collaboration with various payment systems (CMS and Insurance)

Who should Attend

• Company CEOs, CFOs and COOs
• Sponsors
• Clinical Protocol Developers
• Clinical Research Professionals
• Regulatory Managers
• Clinical Study Managers
• Clinical Studies Directors