Tag: promotional claims

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

FDA Holds First OPDP Enforcement Webinar of 2014

Today the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) held its first enforcement webinar of 2014, addressing enforcement actions taken in Q3 and Q4 of 2013.  These enforcement actions included: Q3 2013:  Brovana, Dalfampridine (Ampyra), Naftin, Zevalin Q4 2013:  Aranesp, Benicar, Cedax, Dantrolene Sodium, Diclegis, […]