FDA

FDA CDER’s Christine Moore, PhD, acting deputy director of the Office of New Drug Quality Assessment, explains how her office is leading the Agency in moving from conceptual QbD to actual implementation. Gary Ritchie interviews (with a cameo from Emil Ciurcak).

FDA’s Moheb Nasr’s keynote speech: QbD, Considerations for Analytical Procedures and Control

What kinds of bacteria are growing in your sink or your refrigerator? How about on your keyboard at work? Does soap really reduce the amount of bacteria on your hands? Dr. Keith Lampel of the Food and Drug Administration helps citizen scientists discover the world of bacteria in and around us. Filmed at the Marian Koshland Science Museum in Washington, D.C., this two-part science lab kicked off with a hands-on activity in the museum to observe the invisible bacteria that are present...

In the final episode of this 3 part video series on how to optimize antibiotic use and minimize the emergence of drug resistant pathogens, Dr. Linda Tollefson, Assistant Commissioner for Science at the U.S. Food and Drug Administration, goes in depth on the use of antimicrobial drugs in agriculture, their efficacy, and adverse human health consequences. Dr. Stuart Levy, professor of Molecular Biology and Microbiology at Tufts University School of Medicine, discusses policy, regulatory and...

On September 18, 2008 at the Koshland Science Museum in Washington, D.C., Dr. Stuart Levy, professor of Molecular Biology and Microbiology at Tufts University School of Medicine and Dr. Linda Tollefson, Assistant Commissioner for Science at the U.S. Food and Drug Administration, discussed how to optimize antibiotic use and how to minimize the emergence of drug resistant pathogens. In part 2 of this 3 part video series, Dr. Levy discusses how antibiotic resistance develops, the development...

Will we become defenseless against bacteria? Will bacteria always find a way to infect and even kill us? The emergence of antibiotic resistant strains of bacteria poses an enormous problem around the world. Scientists believe that the overuse of antibiotics is increasing the appearance of these pathogens. In the US, increasing casualties resulting from drug resistant staphylococcus infections received wide media attention. While antibiotics only work on bacterial infections, many patients...