By Mitch Zeller, J.D. In March, I became director of the FDA’s Center for Tobacco Products (CTP) after spending more than three decades working on FDA-related issues, including a seven-year stint at FDA from 1993-2000. From 1997-2000 I was director … Continue reading →
By: Janet Woodcock, M.D. In fiscal year 2012, FDA approved 35 novel new drugs, also known as “new molecular entities.” Among these new products were drugs to treat patients with unmet medical needs, such as a groundbreaking treatment for a … Continue reading →
By: Margaret A. Hamburg, M.D. One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry … Continue reading →
By: Margaret A. Hamburg, M.D. Recently I was privileged to be part of a U.S. delegation to the 66th World Health Assembly (WHA) in Geneva, Switzerland, led by the Secretary of Health and Human Services, Kathleen Sebelius. This is an … Continue reading →
By: Margaret A. Hamburg, M.D. One year ago today President Obama signed into law the Food and Drug Administration Safety and Innovation Act, bipartisan legislation reauthorizing user fee programs for innovator drugs and medical devices and establishing two new user … Continue reading →
By: Margaret A. Hamburg, M.D. When federal agencies celebrated “Small Business Week” last month, FDA had special reason to pay tribute. It is well known that the U.S. biomedical industry plays an essential role not only in advancing the health of … Continue reading →
