Notice to Industry: FDA Issues Draft Guidance for Pre-Launch Importation Requests (PLAIR)
Notice issued: July 24, 2013
The FDA today issued a draft guidance to industry, outlining the agency’s policy on the importation of unapproved finished drug products in anticipation of approval and market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics licensing application (BLA) regulated by FDA’s Center for Drug Evaluation and Research (CDER).
This guidance outlines:
- what information a sponsor should submit to FDA in a pre-launch importation request (PLAIR)
- when and how a PLAIR should be submitted, and
- the circumstances under which FDA intends to grant a PLAIR.
Once a complete PLAIR is submitted, CDER will review the submission and let the applicant know whether the PLAIR has been granted. If FDA grants the PLAIR, the Agency will detain the unapproved drug when it is offered for import for a period of up to 6 months pending a decision on the new drug application. If and when CDER approves the new drug application, FDA’s Office of Regulatory Affairs will make the admissibility decision for the drug import.
Although sponsors may comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers industry comments on the draft guidance before it begins work on the final version of the guidance, electronic or written comments on the draft guidance should be submitted by September 23, 2013. Electronic comments on the draft guidance should be submitted to http://www.regulations.gov. Written comments should be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.