Pre-Launch Activities Importation Requests (PLAIR)

On 1 March 2022 the FDA published the final guidance on the PLAIR for industry.

This guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013. This guidance finalizes FDA's approach for overseeing requests regarding the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This guidance further describes the procedures for making these requests and FDA's actions on such requests. Finalizing this policy will help increase efficiencies in ensuring timely access to drug products upon approval.

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