BioSimilar FDA Accepts Apotex’s Neupogen Biosimilar Application: Raises Issues… Thomas Sullivan Feb 19, 2015 2 Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim,…
DOJ AstraZeneca Pays $7.9 Million To Resolve Kickback Allegations Related to… Thomas Sullivan Feb 18, 2015 0 AstraZeneca last week settled with the Department of Justice over allegedly offering kickbacks to Medco Health…
DOJ DOJ Enforcement Panel Focuses on Medical Device Companies Thomas Sullivan Feb 17, 2015 0 Last week’s CBI Medical Device and Diagnostic Compliance Congress featured an “enforcement panel” that discussed recent trends in…
Open Payments Sunshine Briefing Features Calls for Expansion of Reporting Requirements… Thomas Sullivan Feb 13, 2015 0 The National Coalition on Healthcare recently held a discussion on the Physician Payments Sunshine Act. The discussion…
CMS AdvaMed Releases Innovation Agenda: Proposes Device Tax Repeal; Automatic… Thomas Sullivan Feb 12, 2015 0 The Advanced Medical Technology Association (AdvaMed) on February 10th released a comprehensive set of policy proposals…
CMS CMS Issues Final Rule on Managing Conflicts of Interests in Medicare… Thomas Sullivan Feb 12, 2015 0 In March 2013, the Department of Health and Human Services Office of Inspector General released a report entitled Gaps in…
DOJ Medtronic Settles $2.8 Million Off-Label Suit Over Neurostimulator… Thomas Sullivan Feb 11, 2015 0 Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company…
Uncategorized Physician Payments Sunshine Act: CMS Holds Data Submission Q&A Thomas Sullivan Feb 10, 2015 0 Yesterday, CMS’ Open Payments team held an informal question and answer session. Doug Brown, director of the data sharing and…
FDA FDA Brief Summary and Adequate Directions for Use: Disclosing Risk… Thomas Sullivan Feb 10, 2015 0 FDA: Advertisements “should focus on the most important risk information rather than an exhaustive list of risks.” Over the…
Events Careers in Health Law: Practical Tips for Law Students to Identify Health… Thomas Sullivan Feb 9, 2015 0 The American Bar Association is offering a complimentary law student webinar, "Careers in Health Law: Practical Tips for…