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Unique Challenges When Commercializing Specialty Drugs & How to Mitigate Risk
Sarah S (Nov 12, 2014)
It is understandable that drug companies wish to extend the use of a product they spent considerable time and money developing. Similarly, patients who have been unable to find answers to their medical issues can hardly be blamed for championing off-label use of a medication to help alleviate a problem.

Opening up a drug to uses other than the one explicitly stated on its label, however, brings significant challenges. Regulators must ensure that drug manufacturers aren’t pushing product or advertising it in misleading or untruthful ways. Medical affairs departments and physicians must remain compliant but still do their utmost to help patients.
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