Medical Legal Teva Pharmaceuticals v. Sandoz: Supreme Court Sides with Teva in Patent… Thomas Sullivan Jan 22, 2015 0 The Supreme Court on Tuesday handed down an important decision regarding how patent claims are handled on appeal. The U.S. Court…
CME Physician Payment Sunshine Act: Council of Medical Specialty Societies… Thomas Sullivan Jan 21, 2015 0 Last month, the Centers for Medicare and Medicaid Services (CMS) issued three FAQs and a page of website guidance to supplement…
FDA FDA Looks Into Shorter Risk List In Direct-To-Consumer Ads; Responds to… Thomas Sullivan Jan 20, 2015 0 Drug advertisements that the Food and Drug Administration (FDA) believes minimize a product’s risks have long been one…
CME Industry Involvement in Medical Education: Debunking the Myth Thomas Sullivan Jan 19, 2015 0 A recent article by Harry Pellman, M.D. entitled The importance of bias in education dispels some of the myths about…
HHS-OIG OIG Soliciting Recommendations on New Safe Harbors To The Anti-Kickback… Thomas Sullivan Jan 16, 2015 0 Each year the HHS Office of Inspector General (OIG) solicits recommendations for new or modified safe harbor provisions…
Open Payments Physician Payments Sunshine Act: Open Payments 2015 Timeline; Enhancements… Thomas Sullivan Jan 15, 2015 1 Unlike the first Open Payments program year, which took place over a 5 month period from August 2013 – December 2013, the second…
FDA FDA’s CDER and CDRH Release 2015 Guidance Agenda and Comprehensive Document… Thomas Sullivan Jan 14, 2015 1 The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just…
Corporate Integrity Agreements Daiichi Sankyo Settlement and Corporate Integrity Agreement Thomas Sullivan Jan 13, 2015 0 Japanese pharmaceutical company, Daiichi Sankyo Inc., with U.S. headquarters in New Jersey, has agreed to pay $39 million to…
ACCME ACCME Names Graham T. McMahon, MD, MMSc, as New President and CEO Beginning… Thomas Sullivan Jan 12, 2015 0 The Accreditation Council for Continuing Medical Education (ACCME) Board of Directors today announced that it has chosen…
Events January 27-28: CBI Pharmaceutical Compliance Congress in Washington, D.C.;… Thomas Sullivan Jan 12, 2015 0 CBI's 2015 Pharmaceutical Compliance Congress (PCC) will take place on January 27-28, 2015 at the Ritz Carlton in…