FDA CDER 2017 Guidance Agenda Thomas Sullivan Mar 31, 2017 0 In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and…
CMS Access Problems Persist with Open Payments… Thomas Sullivan Mar 31, 2017 0 With less than two days left to submit and attest to data for the June 30, 2017, publication, manufacturers and group purchasing…
DOJ Bristol-Myers Squibb Settles Off-Label Promotion Case for $19.5 Million Thomas Sullivan Mar 30, 2017 0 Late last year, Bristol-Myers Squibb (BMS) settled with the government to resolve allegations that spanned several states that it…
Uncategorized Medical Devices & False Claims – Shire’s Settlement Is One for the… Thomas Sullivan Mar 30, 2017 0 We have seen many large False Claims and Anti Kickback settlements with pharmaceutical companies and the prescriptions…
Compliance Chicago Releases Draft Rules on Industry Representative Licensure Thomas Sullivan Mar 29, 2017 1 In a city where crime rates are sky-high and illegal drugs are easily picked up on the street, on November 16, 2016, the City of…
Uncategorized Do DPA’s Work? – The BioMet Case Study Thomas Sullivan Mar 29, 2017 0 On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer…
Clinical Trial Transparency Whatever the Question, Transparency Isn’t the Answer Thomas Sullivan Mar 28, 2017 1 Many in political (and non-political) circles have blamed a lack of pricing transparency for increasing healthcare costs. However,…
FDA A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure Thomas Sullivan Mar 28, 2017 0 In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the…
Pharmacy Arizona Enacts Law: Pharmaceutical Companies to Legally Communicate… Thomas Sullivan Mar 27, 2017 0 As many of our readers know all too well, pharmaceutical companies are not permitted to discuss off-label, legal, alternative uses…
CMS “Open” Payments Portal Not So Open Thomas Sullivan Mar 27, 2017 0 Last Friday, several of our readers emailed us last week to let us know that they were having difficulty with logging in and…