- Examining restrictions on pharmaceutical manufacturer activities
- Case studies of inequitable conduct
- Consequences of receipt of a warning or untitled letter for pre-approval promotion
- Managing regulatory limitations on pre-approval company activities during the final stages of FDA review
- Advising the healthcare community of imminent product availability while remaining compliant
- Reviewing FDA regulatory activity and establishing appropriate in-house compliance and education processes
- Maintaining an acceptable separation of science and promotion in press releases announcing clinical trial results
- Presenting clinical trial data in a scientific and objective manner
- Guidance on scientific exchange
- Beyond FDA – the increasing oversight by the Department of Justice, the OIG, and the SEC
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