Prepare for investor meetings with this checklist of six common investor questions. Download Now

Westicke Partners

Close

ICR Westwicke Blog

The ICR 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

Learn to Foster Better Analyst Relationships

Analyst communications play a key role in a company’s success. Download our checklist, 5 Tips for Effective Analyst Communications, for tips to maintain effective analyst relationships. 

Our Locations