FDA FDA Hearing on Innovation and Access Thomas Sullivan Jul 21, 2017 0 Earlier this week, the Food and Drug Administration (FDA) held a public hearing entitled “The Hatch-Waxman Amendments: Ensuring a…
Life Science Compliance Update The California Hurdle – SB 790 and Pharma Thomas Sullivan Jul 21, 2017 0 Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems…
Accountable Care Organizations Accountable Care Organizations: Risk and Reward Thomas Sullivan Jul 20, 2017 0 In January 2015, HHS set the target of funneling 50% of Medicare payments through alternative payment models and tying 90% of…
DOJ Largest Fraud Takedown Announced by AG Sessions Thomas Sullivan Jul 19, 2017 0 On Thursday, July 13, 2017, United States Attorney General Jeff Sessions and Department of Health and Human Services (HHS)…
DOJ Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG… Thomas Sullivan Jul 19, 2017 0 Measuring the effectiveness of compliance programs is no easy task since governing agencies have not published a template that…
Congress United States House of Representatives Passes PDUFA Thomas Sullivan Jul 18, 2017 0 On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the…
ACCME CME Continues to Grow and Evolve Thomas Sullivan Jul 17, 2017 0 The Accreditation Council for Continuing Medical Education (ACCME®) recently released the ACCME Data Report: Growth and Evolution…
Events This is Not Your Parent’s Compliance Program – The New Era of Compliance… Thomas Sullivan Jul 17, 2017 0 At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to…
Pharmaceutical and Device PhRMA Report Shows More than 240 Immuno-Oncology Treatments in Development Thomas Sullivan Jul 14, 2017 0 In early June 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) – in partnership with the American…
FDA FDA Drug Approvals on an Uptick Thomas Sullivan Jul 13, 2017 0 Already in 2017, the FDA has approved a number of new drugs, which Regulatory Focus points out as a trend away from the low number…