Uncategorized Drug Information Association: Comparative Effectiveness Conference Thomas Sullivan Feb 15, 2012 0 We have recently seen a lot of activity regarding the Patient-Centered Outcomes Research Institute (PCORI), an independent,…
Affordable Care Act Road to Reform: The Healthcare Regulatory Burden Thomas Sullivan Feb 15, 2012 0 A recent article from California Healthline looked at some of the regulatory problems our health care system is facing…
ACCME ACCME Launches New Website Thomas Sullivan Feb 14, 2012 0 The Accreditation Council for Continuing Medical Education (ACCME) announced the launch of their redesigned Web site. The…
Conflict of Interest The Difficulty and High Costs in Creating New Medications Thomas Sullivan Feb 14, 2012 0 Over the past several years, there has been significant discussion about the difficulty pharmaceutical and medical device…
Uncategorized FDA Issues Draft Guidance’s on Bio-Similars Thomas Sullivan Feb 13, 2012 0 The U.S. Food and Drug Administration (FDA) last week issued three draft guidance documents on biosimilar product development to…
FDA FDA Using Accountability to Deter Illegal Marketing Activity Thomas Sullivan Feb 10, 2012 0 Using accountability as a tool to deter illegal activity like misbranding and promote corporate transparency was a resounding…
Congress FDA CDRH – MDUFA Agreement and Strategic Priorities for 2012 Thomas Sullivan Feb 9, 2012 0 The FDA and industry recently came to an agreement in principle for the Medical Device User Fee Act (MDUFA), costing the device…
Physician Payment Sunshine Act Physician Payment Sunshine Act: CMS Proposed Rule – Links to Legal… Thomas Sullivan Feb 8, 2012 0 The February 17th deadline is quickly approaching for individuals and stakeholders to submit comments for the proposed regulations…
Pharmaceutical and Device Hospitals Hire Sales Reps to Recruit Referrals Thomas Sullivan Feb 8, 2012 0 Typically, when we think of sales representatives, we see the image of a man or woman dressed in a suit, entering a doctor’s…
Conflict of Interest Convergence of Interest – Not Conflict of Interest Thomas Sullivan Feb 7, 2012 0 Given all the recent coverage of the proposed regulations implementing the Physician Payments Sunshine Act (Section 6002 of the…