Federal Register Notice: FDA is making available a draft guidance for industry entitled How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. It describes how a prospective ANDA applicant may request a letter stating that FDA has determined the following: The potential applicant’s bioequivalence study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use applicable to the reference listed drug (RLD) and FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA. To download this guidance, click here. To view this notice, click here.