March 2017 – Policy & Medicine

CDER 2017 Guidance Agenda

Access Problems Persist with Open Payments…

Bristol-Myers Squibb Settles Off-Label Promotion Case for $19.5 Million

Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

Chicago Releases Draft Rules on Industry Representative Licensure

Do DPA’s Work? – The BioMet Case Study

Whatever the Question, Transparency Isn’t the Answer

A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

Arizona Enacts Law: Pharmaceutical Companies to Legally Communicate Off-Label Treatment to Medical Professionals

“Open” Payments Portal Not So Open