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Importing Drugs with a Pre-Launch Activities Importation Request (PLAIR)

FDA reviews requests and may grant permission in certain circumstances for a manufacturer to import a drug in anticipation of the drug receiving FDA approval. When approved, these pre-launch activities importation requests, or PLAIRs, allow drug sponsors to import unapproved finished drugs.
http://www.fda.gov/drugs/human-drug-imports/importing-drugs-pre-launch-activities-importation-request-plair fda.gov
RSS Hunter RSS Hunter • Jun 15