A crisis can break in an instant. Are you prepared? Use our eBook to develop a plan.Download Now

Westicke Partners

Close

Westwicke Blog

The Westwicke Blog is designed to deliver information and insights into the ever-changing world of healthcare communications.

How New PDUFA Late Cycle Reviews Will Affect Disclosures

Posted on May 8th, 2013. Posted by

How New PDUFA Late Cycle Reviews Will Affect Disclosures

In March 2013, a journalist for The RPM Report (subscription required) wrote that the U.S. Food and Drug Administration (FDA) had held a “late cycle” review meeting with a drug candidate sponsor. The meeting – an element of the 2012 Prescription Drug User Fee Act-V – introduced a new formalization of communication between the FDA and sponsors, and hailed a new investor relations dilemma for companies: Should “sponsors” disclose what is discussed in these late cycle meetings with the agency, or not?

Late cycle review meetings are a change from past FDA practice; previously the agency engaged in less formal, ongoing communications. Formality might be a good administrative move by the FDA. The agency will now more clearly state what page it’s on, rather than making the sponsor figure out the scenario via a stream of communications over several months.

Continue Reading

Navigating an Executive Leadership Change?

With effective communication, you can positively shape public perception and facilitate a smooth transition. Learn more in our eBook, Communications for an Executive Leadership Change.

Our Locations