Pre Launch Activities Importation Requests (PLAIR)

Pre Launch Activities Importation Requests (PLAIR) guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR), which describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug application (ANDA).This guidance also applies to unapproved biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated. Moreover, this guidance describes the procedures for making requests for importation of unapproved finished dosage form drug products before final approval of the application and the factors that FDA will consider in granting such requests.