Pre-Launch Activities Importation Requests (PLAIR)
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Dosage Forms -- standards Drug Approval Drug Development United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR), which describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug application (ANDA).2 This guidance also applies to unapproved biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated. Moreover, this guidance describes the procedures for making requests for importation of unapproved finished dosage form drug products before final approval of the application and the factors that FDA will consider in granting such requests. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (8 pages)).
- NLM Unique ID:
- 9918452088506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918452088506676