REMS are FDA-mandated, post-marketing safety programs that can be required to appropriately balance a drug’s benefits and risks to support safe use. These safety programs are most often required during the NDA or biologics license application (BLA) process to address risks identified in development.

If not planned for, this one requirement can set the launch back months, possibly a year, depending on the complexity of the REMS. This reality hits hard; realizing it could have been avoided hits harder.

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