Representatives of the US Food and Drug Administration and Industry

The following authors contributed to the article, "FDA's Pharmaceutical Quality Initiatives: Implementation of a Modern Risk-based Approach," in the May 2008 issue: Moheb Nasr (FDA), Gerald Migliaccio (Pfizer), Barbara Allen ( Eli Lilly and Company), Robert Baum (Pfizer), Ronald Branning (Genetech), Chi-wan Chen (FDA), Joseph Famulare (FDA), Richard Friedman (FDA), Musa Ghannam (Schering-Plough), Frank Holcombe (FDA), Nirdosh Jagota (Wyeth), Christopher Joneckis (FDA), Zena Kaufman (Abbott Laboratories), Steven Kozlowski (FDA), LaiMing Lee (FDA), Anthony Lubiniecki (Centocor), Mary Malarkey (FDA), Christine Moore (FDA), Elaine Morefield (FDA), Gene Murano (Genentech), Richard Norgard (Pfizer), Helen Winkle (FDA), and Janet Woodcock (FDA).

The US Food and Drug Administration announced its Pharmaceutical GMPs for the 21st Century initiative six years ago. This article reports on the outcome of a recent workshop on this topic and the action plan set forth.