FDA Offers Guidance on Pre-Launch Activities Importation Requests
The Food and Drug Administration (FDA) has made available a draft guidance entitled “Pre-Launch Activities Importation Requests (PLAIR).” Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.
PLAIR will aid the FDA in creating a more formal program to deal with applicants seeking to import unapproved finished dosage form drug products in preparation for market launch. Historically, FDA has considered the requests on a case-by-case basis. The draft guidance provides the agency’s initial steps in creating a formal program on PLAIRs and includes what information should be submitted to FDA in a PLAIR, when and how a PLAIR can be submitted and the circumstances under which the FDA intends to grant a PLAIR. The draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research.