Open Payments Physician Payments Sunshine Act: CMS Will Withhold A Large Amount of… Thomas Sullivan Aug 18, 2014 0 In just over a month, on September 30th, the Centers for Medicare and Medicaid Services (CMS) is scheduled to publish a searchable…
FDA FDA ANDA Submissions Content and Format of Abbreviated New Drug… Thomas Sullivan Aug 18, 2014 0 Recently, the US Food and Drug Administration (FDA) released a new draft guidance document on the content and format of…
Open Payments Physician Payments Sunshine Act: CMS Extends Dispute Window to September 8;… Thomas Sullivan Aug 15, 2014 0 As an update on our continuing coverage of the Open Payments website and physician dispute resolution process, the Centers for…
Open Payments Physician Payments Sunshine Act: Open Payments System Back Up After 11 Days… Thomas Sullivan Aug 15, 2014 0 August 14, 2014: The Centers for Medicare and Medicaid Services (CMS) have fixed the technical problems that caused Open…
Electronic Health Records Health IT Update Summer 2014 Thomas Sullivan Aug 15, 2014 0 We have written previously about the "Meaningful Use" electronic health record (EHR) initiative, which is run by the…
FDA Celgene Faces Off-Label Promotion Lawsuit Over Successful Cancer Drugs… Thomas Sullivan Aug 14, 2014 0 Since 2006, Celgene Corporation has earned $20.9 billion from the sales of two of its drugs—Thalomid and Revlimid. The drugs are…
Medical Legal Antitrust Lawsuit Against Celgene Over Thalomid and Revlimid Focuses on… Thomas Sullivan Aug 14, 2014 0 Celgene's successful cancer drugs Thalomid and Revlimid are at the center of an antitrust action. On April 3rd, Mylan…
Clinical Research European Medicines Agency Inching Towards Clinical Trial Transparency Thomas Sullivan Aug 13, 2014 0 The European Medicines Agency (EMA) Management Board has been inching towards a policy on clinical trial transparency.…
Drug Shortages Public Distrust of Pharmaceutical Industry Could Harm Research and… Thomas Sullivan Aug 12, 2014 0 A recent article in Forbes argues that misplaced public distrust of the pharmaceutical industry could harm the research and…
Institute of Medicine Institute of Medicine Recommends Value-Based Payment System and More… Thomas Sullivan Aug 12, 2014 0 "There is a striking absence of transparency and accountability in the GME financing system for producing the types of physicians…