FDA Reveals Criteria For Importing Unapproved Drugs

Law360, New York (July 24, 2013, 3:57 PM EDT) -- The U.S. Food and Drug Administration on Wednesday unveiled guidance on when it will permit unapproved prescription drugs to be imported into the country in anticipation of commercial launch, moving away from a long-standing case-by-case approach.

The draft document concerns so-called Pre-Launch Activities Importation Requests, or PLAIRs, that manufacturers of branded and generic drugs submit shortly before they expect to receive FDA approval to sell their products. Nearly 200 such applications are expected annually from about 50 different drugmakers, the agency projects.

Federal law ostensibly bars...
To view the full article, register now.