How to Obtain a Letter from the FDA Stating Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

Summary

The FDA is releasing a draft guidance that explains how a generic drug manufacturer can request a letter stating that their bioequivalence study protocols meet safety standards comparable to the reference listed drug's risk evaluation and mitigation strategy. This letter would allow the generic firm to obtain the necessary reference drug for testing without violating the reference drug's safety protocols.