FDA FDA Expanded Access to Investigational Drugs for Treatment Use: Draft… Thomas Sullivan Jun 25, 2013 0 The Food and Drug Administration (FDA) recently released a Draft Guidance for Industry, in the form of Question and Answer (Qs…
Electronic Health Records HHS OIG Proposes Safe Harbor for Electronic Health Records Thomas Sullivan Jun 24, 2013 0 The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a proposed rule to create…
HHS-OIG HHS OIG Issues Exclusion Advisory Thomas Sullivan Jun 21, 2013 0 The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently issued an Updated…
International EFPIA Transparency Guidelines: Reporting Payments in Europe Thomas Sullivan Jun 21, 2013 0 In a recent update from the international law firm Fulbright & Jaworski, through its soon-to-be new firm Norton Fulbright (now…
Institute of Medicine NIH – NHLBI Discontinues Guidelines Program Passes Work off to… Thomas Sullivan Jun 20, 2013 0 Over the years, we have written about the important role clinical practice guidelines play in physician care and treatment of…
FDA FDA Expanding Role of Office of Criminal Investigations Thomas Sullivan Jun 20, 2013 0 Over the last year or two, the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has grown to play a…
HHS-OIG Physician Payment Sunshine Act: HHS OIG Reports the NPPES Database as… Thomas Sullivan Jun 19, 2013 0 The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a report titled…
PCORI PCORI Funding Announcement – Clinical Data and Patient Powered Research… Thomas Sullivan Jun 19, 2013 0 In late April of this year, the Patient-Centered Outcomes Research Institute (PCORI) announced two new funding opportunities…
FDA FDA Proposes Making Product Approval Applications More Transparent Thomas Sullivan Jun 18, 2013 0 The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of…
Affordable Care Act American Medical Association House of Delegates Features Discussions on… Thomas Sullivan Jun 17, 2013 0 The week the American Medical Association (AMA) is holding its annual meeting. The AMA annual meeting and its House of Delegates…