Orphan Drugs Had A Big 2014, Including Unprecedented Approval Rates
Recognizing that drug companies would actually incur a financial loss in developing important drugs for rare conditions,…
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FDA Accepts Apotex’s Neupogen Biosimilar Application: Raises Issues…
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim,…
AstraZeneca Pays $7.9 Million To Resolve Kickback Allegations Related to…
AstraZeneca last week settled with the Department of Justice over allegedly offering kickbacks to Medco Health…
DOJ Enforcement Panel Focuses on Medical Device Companies
Last week’s CBI Medical Device and Diagnostic Compliance Congress featured an “enforcement panel” that discussed recent trends in…
Sunshine Briefing Features Calls for Expansion of Reporting Requirements…
The National Coalition on Healthcare recently held a discussion on the Physician Payments Sunshine Act. The discussion…
AdvaMed Releases Innovation Agenda: Proposes Device Tax Repeal; Automatic…
The Advanced Medical Technology Association (AdvaMed) on February 10th released a comprehensive set of policy proposals…
CMS Issues Final Rule on Managing Conflicts of Interests in Medicare…
In March 2013, the Department of Health and Human Services Office of Inspector General released a report entitled Gaps in…
Medtronic Settles $2.8 Million Off-Label Suit Over Neurostimulator…
Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company…
Physician Payments Sunshine Act: CMS Holds Data Submission Q&A
Yesterday, CMS’ Open Payments team held an informal question and answer session. Doug Brown, director of the data sharing and…
FDA Brief Summary and Adequate Directions for Use: Disclosing Risk…
FDA: Advertisements “should focus on the most important risk information rather than an exhaustive list of risks.”
Over the…