In a Federal Register notice published on July 24, 2013, the Food and Drug Administration (FDA) announced that a draft guidance for industry on Pre-Launch Activities Importation Request (PLAIR), outlining FDA's policy on requests for the importation unapproved finished drugs is now available.

In the notice, FDA explains that " Historically, when applicants sought to import unapproved finished dosage form drug products in preparation for market launch, FDA considered such requests, informally referred to as PLAIRs, on a case-by-case basis."

In the notice, FDA explains that, going forward, a more formal program will be implemented for these kinds of requests. The draft guide will provide information the on the following:

• What information should be submitted to FDA in a PLAIR
• When and how the information should be sent for the request
• Under what circumstances FDA will grant a PLAIR

FDA recommends that comments should be submitted by September 23, 2013, although they will be accepted at any time.

The full text of the Federal Register notice is available online here. The PLAIR draft guidance is available here.