FDA Finalizes PLAIR Guidance, Setting Import Windows for Pre-Approval Drug Launches

Regulatory affairs teams managing imminent NDA or BLA approvals now have a codified federal framework for importing finished drug product before approval is granted. FDA's final guidance on Pre-Launch Activities Importation Requests (PLAIRs) establishes the conditions under which sponsors may bring unapproved finished drugs into the United States in anticipation of market authorization, directly affecting how supply chain and regulatory operations teams sequence pre-launch logistics.

Under the policy, a PLAIR must generally be submitted no more than 60 days before the user-fee goal date. Applications carrying a priority review designation are eligible for an extended window, permitting submission up to 120 days before that date. The distinction is operationally significant: priority review products move on compressed timelines, and the wider import window gives manufacturing and distribution teams additional lead time to position inventory without triggering premature commercial activity.

The guidance situates PLAIRs within the broader FD&C Act framework, emphasizing that FDA retains review and approval authority over each request. Unapproved drugs imported under a granted PLAIR remain subject to control and tracking requirements, meaning QA and regulatory leads should treat PLAIR-imported product with the same chain-of-custody discipline applied to any pre-approval material held pending release.

Submission is routed through the CDER NexGen Portal, which FDA specifies as the required channel to expedite processing. The portal incorporates multi-factor authentication, a data-security measure FDA frames explicitly around protecting drug supply chain integrity. Regulatory operations teams not yet enrolled in NexGen should treat portal access as a prerequisite step, not a parallel workstream.

The finalized guidance gives sponsors a defined compliance pathway that, if followed precisely, can compress the gap between approval and first commercial shipment without exposing the organization to import violations.

Source: FDA via What's New: Drugs RSS Feed, June 15, 2026.