By: Margaret A. Hamburg, M.D. To say that Rick Pazdur faces enormous challenges in his job is an understatement. To say that he faces each day with energy, insight and resolve still falls short of the mark. It’s my privilege … Continue reading →
By: Janet Woodcock, M.D. This week the FDA will convene two advisory committees to discuss the results a readjudication, or independent review, of the results of a large, long-term study on whether patients are at greater risk of heart attack or … Continue reading →
By: John Roth In my last post, I explained how FDA’s Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory … Continue reading →
