Magazine Article | November 1, 2023

Understanding The FDA's Current Focus On REMS

Source: Life Science Leader

By Life Science Connect Editorial Staff

Earlier this year, the FDA asked for comments about how the government handles change requests from drug sponsors with risk evaluation and mitigation strategies (REMS).

More specifically, the agency wanted comments on considerations the Health and Human Services secretary should make when weighing sponsor companies’ requests to change third-party vendors who help implement and manage REMS.

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