FDA: Import of Drugs prior to approval

Recommendation

27-29 February 2024

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Management, Supply and Quality Assurance of Clinical Trials

The U.S. Food and Drug Administration FDA has issued a draft guidance to define how the agency intends to deal with requests to import unapproved drug products. If a manufacturer anticipates approval and wants to prepare market launch, requests would be currently considered on a case by case basis.

Now, the idea is to create a formal process for the so called Pre-Launch Activities Importation Request (PLAIR). In its new draft Guidance for Industry "Pre-Launch Activities Importation Requests (PLAIR)", FDA outlines what FDA will expect to be included in a PLAIR and when it should be submitted. It also includes the actions FDA will take on a PLAIR and the following steps.

The guidance "Pre-Launch Activities Importation Requests (PLAIR)" applies only to finished dosage form drug products, anticipating approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA).

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register.