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…
Corporate Integrity Agreements HHS OIG: Listing of Pharmaceutical and Device Corporate Integrity… Thomas Sullivan Feb 22, 2013 0 Below is a list in alphabetic order of the major pharmaceutical and medical device manufacturer corporate integrity agreements…
National Physician Payment Transparency Program Physician Payment Sunshine Act: CMS Launches National Physician Payment… Thomas Sullivan Feb 21, 2013 0 This week, the Centers for Medicare & Medicaid Services (CMS) launched a website which will host the National Physician…
Congress CBO Report: Improved Patient Adherence Benefits Medicare Thomas Sullivan Feb 20, 2013 1 Prescription medicines help people avoid the disability and death caused by disease, and help lower overall treatment costs. In…
Physician Payment Sunshine Act: Final Rule Physician Payment Sunshine Act Final Rule: ACCME – CMS Validated the… Thomas Sullivan Feb 19, 2013 0 As we noted earlier this month, the Centers for Medicare & Medicaid Services (CMS) released the final regulations to implement…
Corporate Integrity Agreements Amgen Settlement and Corporate Integrity Agreement Thomas Sullivan Feb 19, 2013 0 Adding to the long list of pharmaceutical settlements involving off-label promotion, Amgen Inc., the world’s largest biotechnology…
CME CME – When Old Beliefs Won’t Budge: Evaluating Entrenched Attitudes… Thomas Sullivan Feb 18, 2013 0 Each year, the Alliance for Continuing Education in the Health Professions (ACEHP) holds its annual meeting, bringing together…
Academic Organizations Industry, Academic, Foundation and Government Alliances Continue in Early… Thomas Sullivan Feb 15, 2013 0 As promised, we are continuing to provide coverage of newly announced or recently discovered collaborations between industry,…