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DOJ increasing enforcement on off-label …
- https://www.sedgwick.com/blog/2021/06/02/doj-increasing-enforcement-on-off-label-promotion-heres-what-to-expect
- Off-label promotion comes in two forms: marketing a device or drug that has not received FDA approval, or promoting an approved device for an …
Off-Label Use of Marketed Drug or Device
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/label-and-investigational-use-marketed-drugs-biologics-and-medical-devices
- Office of Communication, Outreach and Development Center for Biologic Evaluation and Research Food and Drug Administration 10903 New Hampshire …
FDA Issues Final Rule Clarifying Evidence of Off-Label …
- https://www.dechert.com/knowledge/onpoint/2021/8/fda-issues--final-rule--on-drug-and-medical-device-marketing.html
- First, the Final Rule clarifies that the FDA will not make a determination of a company’s intent regarding off-label use based solely on knowledge that its product is being …
DOJ’s Evolving Enforcement Approach to Off-Label …
- https://www.skadden.com/insights/publications/2021/04/enforcement-in-life-sciences-series/dojs-evolving-enforcement-approach
- The government has responded by focusing on cases where the facts indicate that promotional messaging is false or misleading, including where promotion …
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