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| Janet Woodcock |
On Monday, the FDA launched its long-discussed Office of Pharmaceutical Quality, although a director is not yet in place. Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), will oversee it until a director is found. She said in a briefing Monday that over the next couple of years, the new office will establish benchmarks that will allow the FDA to better understand which plants need to be more closely monitored, Reuters reports. The quantitative information will replace the more general ideas the agency has had about the state of manufacturing quality. The FDA in recent years has stepped up its expectations, taking actions that have led to plant closures, and sometimes drug shortages. The agency has also stepped up its manufacturing oversight internationally, particularly in India and China, two countries that supply many of the generic drugs and ingredients used in U.S. pharmaceuticals. The agency has been pushing the industry to create a "culture of quality," hoping to reduce the number of plant closures and recalled drugs and to better protect consumers. Story | More