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

This training on FDA 21 CFR Part 312 regulations will focus on expanded access rules for charging for an investigational drug. The attendees will understand the complexity of approval process and will learn the best practices for gaining approval.

Why Should You Attend:

This webinar will dissect the regulations for charging for an investigational drug.

This webinar will discuss:

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

Detail by detail, this webinar will introduce you to the process of gaining approval to charge for your investigational drug.

For Registration:

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703092?channel=worldconf