Topics
- What the law of off-label promotion of drugs and devices is
- What drug and device labeling is and is not
- Why drug and device firms favor off-label communications
- How freedom of speech and the First Amendment may be important
- Changes that occurred to off-label communications with the onset of the Internet
- Earlier FDA Guidance regarding off-label communications to learned intermediaries
- What the Guidance covers and what it does not include
- The long awaited FDA Guidance explained
- Using the developed protocol to follow FDA Guidance on off-label claims
- Establishing procedures to have a viable and compliant off-label policy
- The use of risk management in an effective manner to promote off-label claims based upon freedom of speech
Who should Attend
Attendees from drug and device companies, including Labeling, VP, Marketing, IT, Regulatory Affairs, Top management and Product Development.
