The Food and Drug Administration (FDA) will hold a workshop on January 9, 2007, to provide information, clarification and guidance to sponsors seeking approval to legally market prescription and over-the-counter drugs through the New Drug Application (NDA), abbreviated New Drug Application (ANDA) and monograph processes.

The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be safe and effective prior to marketing and widespread use in the general population. However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally -- without required FDA approval. While some unapproved drugs may have benefits, there may also be risks. Drugs marketed without FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.

In June 2006, FDA issued a revised Compliance Policy Guide (CPG), which makes clear that firms unlawfully marketing drugs need to submit applications showing that their products are safe and effective before continuing to market those products. Following the publication of the CPG (Section 440.100, "Marketed Unapproved Drugs"), many drug companies contacted FDA seeking clarification. The companies wanted information regarding how to obtain approval to legally market their currently unapproved drug products, and whether applications for marketing are subject to user fees, among other things.

The agency is committed to working with companies to facilitate the process of ensuring that products are safe and effective and meet appropriate standards for manufacturing and labeling.

The workshop will be held on January 9, 2007, from 9:00 AM until 4:00 PM in the Advisors and Consultants Staff conference room located at 5630 Fishers Lane, Rockville, Maryland. A notice announcing the meeting and giving registration details is expected to be published in the Federal Register on November 1, 2006. The agenda, when finalized, will be posted on FDA's web site at http://www.fda.gov/cder/drug/unapproved_drugs.