Healthcare Reform Politico Healthcare Briefing: What’s Next for Drug Costs? Thomas Sullivan Jan 27, 2017 0 Late last year, Politico Pro’s Health Care Team, along with CVS Health, held a conversation on the future of prescription drug…
BioSimilar FDA Extends Wait for Biosimilar Interchangeability Guidance Thomas Sullivan Jan 26, 2017 0 The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime…
FDA FDA Releases Draft Guidance on Manufacturer Communications with Payors,… Thomas Sullivan Jan 26, 2017 0 In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled “Drug and Device…
Guidelines Final Common Rule – Sixteen Agencies Update Regulations on… Thomas Sullivan Jan 25, 2017 0 The Department of Health and Human Services (HHS), along with fifteen other federal agencies, issued a final rule updating…
Life Science Compliance Update Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as… Thomas Sullivan Jan 25, 2017 0 Discounts within the health care industry are historically viewed as not being subject to the U.S. Federal Anti-Kick Back Statutes…
FDA FDA Releases Draft Guidance for Medical Product Communications Consistent… Thomas Sullivan Jan 24, 2017 0 The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…
BioSimilar FDA Releases Draft Guidance for Industry on Biosimilar Interchangeability Thomas Sullivan Jan 24, 2017 0 On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating…
Congress U.S. Senators Collins and McCaskill Release Drug Pricing Investigation… Thomas Sullivan Jan 23, 2017 0 United States Senators Susan Collins (R-ME) and Claire McCaskill (D-MO), the Chairwoman and Ranking Member of the Senate Aging…
Life Science Compliance Update Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from… Thomas Sullivan Jan 23, 2017 0 DOJ may have a new focus for Anti-Kickback Statute violations: care facilities and their owners. This year alone, at least two…
FCPA The Trump Administration: One Predictive Perspective Thomas Sullivan Jan 20, 2017 0 We recently had the pleasure of speaking with Michaeline Daboul, President and CEO of MediSpend, about the upcoming administration…