FDA FDA Report Shows NDA and BLA Filings on the Rise in the First Quarter of FY… Thomas Sullivan Aug 8, 2019 0 The US Food and Drug Administration (“FDA”) recently published its quarterly Real Time Report on new drug application (“NDA”) and…
Uncategorized HHS OIG Publishes Semiannual Report to Congress Detailing Efforts to Combat… Thomas Sullivan Aug 7, 2019 0 The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published its Spring 2019 Semiannual…
DOJ NECC Conspiracy Convictions Overturned on Legal Impossibility Theory Thomas Sullivan Aug 6, 2019 0 Last month, a federal judge in Boston overturned the convictions of two former employees of New England Compounding Center…
Drug Prices FTC Report Finds Fewer Anticompetitive Reverse Payment Deals in… Thomas Sullivan Aug 5, 2019 0 The Federal Trade Commission’s (“FTC”) Bureau of Competition published a report that found that, despite an increase in the total…
State Policy Nevada DHHS Releases Updated Transparency Draft Reporting Templates Thomas Sullivan Aug 5, 2019 0 Last week, the Nevada Department of Health and Human Services (DHHS) released updated drug transparency draft reporting templates…
DTC FDA Issues Enforcement Letter Regarding Eskata Risks Omitted From DTC… Thomas Sullivan Aug 2, 2019 0 The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter…
Drug Prices HHS and FDA Offer Two Pathways to Drug Importation Thomas Sullivan Aug 1, 2019 0 On July 31, 2019, the United States Department of Health and Human Services (HHS), in conjunction with the Food and Drug…
CME CMS 2020 Proposed Physician Fee Schedule Includes Changes to the Open… Thomas Sullivan Jul 31, 2019 0 On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that includes proposals to update…
CMS CMS Proposed Rule Would Expedite Part D Prior Authorization Requirements Thomas Sullivan Jul 30, 2019 0 The Centers for Medicare and Medicaid Services (“CMS”) recently published a proposed rule entitled Secure Electronic Prior…
Anti Kickback DOJ Brings Enforcement Actions Against Hospitals For Kickbacks Related to… Thomas Sullivan Jul 29, 2019 0 The US Department of Justice (“DOJ”) recently charged Wheeling Hospital, Inc., located in Wheeling, West Virginia, with violations…