In early December, FDA released a draft guidance on how to request a letter stating that a potential applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD). Obtaining a REMS equivalence letter would allow ANDA applicants to avoid violations when a RLD sponsor provides drug product for testing.
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