FDA FDA Centers for Drug Evaluation and Research: Project Quicker Approval… Thomas Sullivan Mar 7, 2013 0 This past summer, Congress passed and President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA)…
Massachusetts Code of Conduct Massachusetts Posts 2011 Payments to Healthcare Providers: 3% Drop in… Thomas Sullivan Mar 6, 2013 0 As we have covered numerous times on this website, in 2009, the State of Massachusetts enacted the Massachusetts Pharmaceutical…
Open Payments Physician Payment Sunshine Act: Sunshine Alerts and Analysis Thomas Sullivan Mar 5, 2013 0 Now that stakeholders have had a few weeks to read the final rules and begin implementing the Physician Payment Sunshine Act, we…
Physician Payment Sunshine Act: Final Rule Physician Payment Sunshine Act: Survey Shows Physicians Still Unaware of… Thomas Sullivan Mar 5, 2013 0 According to a recent survey, some physicians actually know less about the Sunshine Act provision of the Patient Protection and…
Clinical Research GSK Opens Patient Level Data and Clinical Study Reports Available to… Thomas Sullivan Mar 4, 2013 0 Late last year, we reported that GlaxoSmithKline promised to make detailed data from its clinical trials available to independent…
Drug Shortages Tufts Center for the Study of Drug Development: Study on the Structural… Thomas Sullivan Mar 1, 2013 0 Pharm Exec recently asked the Tufts Center for the Study of Drug Development (TCSDD) to summarize new survey research—partly…
Academic Organizations Strict Conflict of interest Policies at Academic Medical Centers Lead to… Thomas Sullivan Feb 28, 2013 2 We have dedicated a large portion of this blog to covering “conflicts of interest” or COIs, and the various claims being made…
Drug Shortages FDA Strategic Plan to Address Drug Shortages, Solicitation for Comment Thomas Sullivan Feb 27, 2013 0 Earlier this month, the Food and Drug Administration (FDA) released a notice for public comment in the Federal Register regarding…
DOJ DOJ to Target Pharma and Device Current Good Manufacturing Practices (cGMP)… Thomas Sullivan Feb 26, 2013 1 Over the last several years, we have written extensively about the ongoing government prosecution of pharmaceutical and medical…
FDA HHS OIG Report: FDA Lacks Comprehensive Data to Determine Whether Risk… Thomas Sullivan Feb 25, 2013 1 The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) released a report, which asserts…