FDA's Guidance Could Disrupt Product Development, Patient Care, and Billions of Dollars in Investment

Scientia Advisors' Patrick Terry, Principal, Harry Glorikian, Managing Partner and Santosh Kuruvilla, Senior Analyst, published a blog titled "FDA's Guidance Could Disrupt Product Development, Patient Care, and Billions of Dollars in Investment."

Can an FDA Frequently Asked Questions (FAC) document be a game changer for industry? The recently introduced "Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions" may be a case in point. It is the latest in a line of documents that could profoundly affect a number of industry stakeholders, but were introduced without the formal and more thoughtful regulatory development process.

In this post, the authors provide an evaluation of the FDA's Frequently Asked Questions document and the potential implications it may have on clinical diagnostics developers, applied translational medicine enterprises, and even established patient care.

This post can be accessed on the Scientia Advisors blog.

For the full presentation on the Stakeholders Involved with FDA's Guidance, download below.