FDA Posts Draft Guidance on Drug Pre-Approval Importation Requests
The Food and Drug Administration is asking for comments by Sept. 23 on a newly-posted draft guidance on Pre-Launch Activities Importation Requests (PLAIR) for drugs (here). PLAIRs are used to import unapproved finished dosage form drug products when the importer…
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anticipates imminent approval of a new drug application or abbreviated new drug application. Under the PLAIR, unapproved may be imported for relabeling or reconditioning, but are considered to be detained by FDA and so cannot enter into U.S. commerce. Historically, FDA has used examined PLAIRS on a case-by-case basis, but the agency is now creating a formal program, it said. The draft guidance outlines what information should be submitted to FDA in a PLAIR, when and how a PLAIR can be submitted, and the circumstances under which FDA will grant a PLAIR.