Charging for Investigational Drugs: Current Application of 21 CFR Part 312 and the Expanded Access Rules 2013 is a webinar that covers topics such as:
- 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)
Charging for Investigational Drugs: Current Application of 21 CFR Part 312 and the Expanded Access Rules 2013 is intended for:
- Company CEOs, CFOs and COOs
- Sponsors
- Clinical Protocol Developers
- Clinical Research Professionals
- Regulatory Managers
- Clinical Study Managers
- Clinical Studies Directors
