Where does the line fall between good faith and criminal intent? That was the question that a Massachusetts federal jury faced in July as it deliberated criminal charges against William Facteau and Patrick Fabian, ex-Acclarent executives, who were indicted on multiple charges of fraud and misbranding a medical device. Acclarent's device, the Relieva Stratus Microflow Spacer ("Stratus"), was cleared by the FDA for use as a spacer to maintain an opening in the sinus. Although the FDA expressly rejected Acclarant's request to expand the indicated use of the device to include delivery ...
by Wendy C. Goldstein and Kathleen A. Peterson
On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.
The FDA has a longstanding policy of permitting ...
Blog Editors
Recent Updates
- DEA Issues Third Extension to Public Health Emergency Telemedicine Prescribing Flexibilities, Through 2025
- CMS Issuing First Risk Adjustment Data Validation Audit Notices for PY2018 Since the RADV Final Rule
- Just Released: Telemental Health Laws – Download Our Complimentary Survey and App
- HISAA: New Legislation Would Bring Cybersecurity Requirements for HIPAA Covered Entities and Business Associates
- Post-Hurricane Flexibilities Offered by the U.S. Department of Health and Human Services Through the Centers for Medicare & Medicaid Services