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5 Ways to Legally Share Off-Label Information
Manage episode 399801728 series 3506216
Innhold levert av Darshan Kulkarni. Alt podcastinnhold, inkludert episoder, grafikk og podcastbeskrivelser, lastes opp og leveres direkte av Darshan Kulkarni eller deres podcastplattformpartner. Hvis du tror at noen bruker det opphavsrettsbeskyttede verket ditt uten din tillatelse, kan du følge prosessen skissert her https://no.player.fm/legal.
In this episode, the focus is on navigating the complex landscape of off-label information sharing, exploring legal aspects in the context of the life sciences industry. Sponsored by the Kulkarni Law Firm, the episode highlights key points:
1. Scientific discussions: Courts are generally cautious about FDA scrutiny in scientific discussions, such as those in academic conferences or scholarly articles, falling within FDA safe harbors.
2. Consistent with label guidance from the FDA: Sharing information aligning with the appropriate use of a drug or device, even if not explicitly mentioned, is legally acceptable.
3. FDAMA 114: The guidance emphasizes sharing health economic information, including off-label data, with specific entities.
4. SIUU guidance: It introduces a nuanced framework for discussing information implying off-label use, necessitating companies' awareness of its implications.
5. Education and non-company representatives: Engaging in discussions independent of pharmaceutical companies, provide crucial avenues for off-label information sharing, avoiding FDA scrutiny.
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