FDA recently released draft guidance on the process by which an ANDA applicant may obtain a letter from FDA to facilitate the ANDA's efforts to obtain reference listed drug ("RLD") product for bioequivalence testing. By way of background, FDA notes that in some instances, RLD sponsors have refused to sell drug product to ANDA applicants on the ground that doing so would violate the elements to assure safe use ("ETASU") requirements of the product's risk evaluation and mitigation strategy ("REMS"). Historically, at the request of the potential ANDA applicant, FDA has (i) reviewed the bioequivalence study protocols to assess whether the proposed safety precautions are comparable to the ETASU, and if so, (ii) issued letters to RLD sponsors stating so and indicating that supplying the drug product would not be considered a violation of the REMS. The draft guidance document distills FDA's practice to writing to clarify procedures and allow consideration by stakeholders. FDA emphasizes that requesting such a letter is not a legal requirement and that the guidance is intended to clarify the process if the ANDA applicant chooses to do so. Comments due February 3, 2015.
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