DESI drug compliance policy guide

Executive Summary

FDA announces draft compliance policy guide Oct. 17 for drugs that were subject to the Drug Efficacy Study Implementation program and are marketed without an approved NDA or ANDA. Guide outlines FDA policies to encourage companies to sponsor drugs through the approval process. Document also describes for public comment the agency's enforcement approach, which gives highest priority to products that pose the most likely risk to public safety, either because of inherent safety concerns or because there are alternative, FDA-approved treatments available, the agency said. Development of guide was prompted by petition from a group of manufacturers and distributors of Rx extended-release guaifenesin, which have been directed by FDA to remove their products from the market because they have not cleared the approval process (1"The Tan Sheet" March 3, 2003, p. 4)...