The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). The Final Guidance outlines FDA’s policy for the importation of unapproved finished dosage form drug products an applicant is preparing for a U.S. market launch based on anticipated approval of a pending new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics licensing application regulated by FDA’s Center for Drug Evaluation and Research (CDER). The guidance describes the procedures for making such a request to FDA before final approval of the application and provides factors the Agency will consider in granting such requests. FDA offers the following procedural information in the Final Guidance: (1) what information should be submitted to FDA in a PLAIR; (2) when and how to submit a PLAIR; and (3) the circumstances under which the Agency intends to grant a PLAIR.
The Final Guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. Click the link below for a summary of the major provisions in the Final Guidance, as well as our takeaways to assist industry in preparing and submitting PLAIRs.