The review showed a letter volume on the decline (n=524 for 1998-2005, n=239 for 2006-2013), with an increase in PRO violations: 19.50% of all letters (1998-2005) vs. 30.5% (2006-2013). HRQL violations were rarer after 2006 and were more often detected as implicit: 20 false HRQL...
an acquired taste). Many of us remember the classic scene from the 1975 movieMonty Python and the Holy Grail, where John Cleese brings a sickly man to the plague cart, which is touring the village for dead people, and the elderly man says, “I’m not dead yet...
But in 2021, given the significant drop in OPDP enforcement letters and post publication of FDA’s Guidance on Medical Communications Consistent with the FDA-Required Labeling (Guidance), are these the type of claims to trigger an OPDP Untitled Letter? The claims, themselves, seem awfully similar...
Letters See generally The Office of Prescription Drug Promotion (OPDP), U.S. Off-label prescribing in a vulnerable pediatric marketplace The OPDP regulations and guidance documents provide a framework within which the pharmaceutical industry can develop commercial material containing claims that are accu...
2012 Year in Review: FDA OPDP Warning Letters and Untitled LettersRogers, Daniel R
2015 Year in Review: OPDP and APLB Warning and Untitled LettersWeeden, C'Reda J
2014 Year in Review: OPDP Warning and Untitled LettersRogers, Daniel R