Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013.
The FDA says that it considered comments received on the document and noted that “[O]ne change we made in response to comments was to include recommended timeframes for earlier submission of certain PLAIR-eligible products subject to priority review.”
A quick read of the document also suggest that minor editorial changes have been made, as well as the use of different terms in some instances, but please review it in detail as there are specific issues that must be addressed in an orderly manner. The document (here) “outlines which products the PLAIR program covers, what information should be submitted to FDA in a PLAIR, when and how we recommend submitting a PLAIR, and the process for FDA’s action on a PLAIR”.
The detail should permit foreign applicants and their US Agents to be able to wade through the system to accomplish the required tasks in order to assure that their product is at the starting line from a regulatory vantage point and ready to be released upon approval.