FDA to hold workshop on unapproved drugs

The US Food and Drug Administration is to hold a public workshop on January 9, 2007, on the topic of marketed unapproved drugs. The event's stated objective, according to the agency, is "to provide information, clarification and guidance to sponsors seeking approval to legally market prescription and over-the-counter drugs through the New Drug Application, Abbreviated New Drug Application and monograph processes."

The event follows the recent publication by the FDA of a revised Compliance Policy Guide, which aims to crack-down on often older, unapproved drugs which continue to be sold in the USA (Marketletters passim).