FTC Mallinckrodt to Pay $100M to Settle Antitrust Violations Thomas Sullivan Jan 31, 2017 0 Mallinckrodt ARD Inc., formerly known as Questcor Pharmaceuticals, Inc., and its parent company, Mallinckrodt plc, have agreed to…
Congress Senate Finance Committee Holds Hearing on Dr. Price to Lead Department of… Thomas Sullivan Jan 30, 2017 0 On Tuesday, January 24, 2017, the Senate Committee on Finance held a hearing to consider the nomination of Representative Thomas…
CME Education at ACC Chapter Meetings Positively Impacts Management of Severe… Thomas Sullivan Jan 30, 2017 0 Despite guideline-directed statin therapy, the majority of patients with severe hypercholesterolemia and other high-risk…
DOJ Advanced BioHealing (Shire) Settlement Largest in Medical Device History Thomas Sullivan Jan 27, 2017 0 Earlier this month, the Department of Justice (DOJ) announced that Shire Pharmaceuticals LLC and other subsidiaries of Shire plc…
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FDA FDA Releases Draft Guidance on Manufacturer Communications with Payors,… Thomas Sullivan Jan 26, 2017 0 In mid-January 2017, the United States Food and Drug Administration (FDA) released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FDA FDA Releases Draft Guidance for Medical Product Communications Consistent… Thomas Sullivan Jan 24, 2017 0 The United States Food and Drug Administration (FDA) released a new draft guidance that provides information for medical product…