Abstract
Multiple tasks must be performed by the regulatory professional before the critical on-site due diligence meeting occurs in a private data room. Due diligence typically occurs in a secured data room format because the intellectual property (IP) is highly confidential, though, with the advent of virtual data rooms (VDRs [1]), IP is frequently shared before a formal data room exercise and can bring the entire due diligence process forward.
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Notes
- 1.
Technically, the FDA approves the label, not the product itself. No drug/device/biologic, however, can be marketed in the USA without FDA-approved labeling.
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© 2012 Springer Science+Business Media New York
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Huml, R.A. (2012). The On-Site Due Diligence/Data Room Meeting and Interactions with Other Functional Area Experts. In: Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. SpringerBriefs in Pharmaceutical Science & Drug Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3682-9_4
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DOI: https://doi.org/10.1007/978-1-4614-3682-9_4
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