Off-Label Communication Growth: Could FDA Afford To Police It?

Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.

Even if FDA is amenable to allowing more manufacturer communication about off-label uses, FDA may have trouble finding the money to police it.

During the second day of FDA's public hearing on the subject, one stakeholder was concerned that the growth in off-label...

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