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GUIDANCE DOCUMENT

Pre-Launch Activities Importation Requests (PLAIR) July 2013

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-0836
Issued by:
Guidance Issuing Office
Office of the Commissioner

This guidance describes the Food and Drug Administration (FDA or the Agency) policy 19 regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for market launch, based on anticipated approval of a pending 21 new drug application (NDA) or an abbreviated new drug application (ANDA). This guidance 22 also applies to biologics licensing applications (BLA) regulated by the Center for Drug 23 Evaluation and Research (CDER). This guidance further describes the procedures for making 24 these requests and the factors that FDA will consider in granting such requests.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0836.

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