By Stephen M. Hahn MD – If you want to know the FDA’s impact on COVID-19, look no further than the numbers. In a few short months, the agency’s Center for Devices and Radiological Health’s response to the pandemic has been unprecedented in terms of volume, speed, and agility – spanning multiple areas, including:
By Janet Woodcock MD & Theresa M. Michele MD – Skin cancer incidence rates continue to rise, making risk from excess sun exposure an important public health priority. Yet despite what we know about prevention, skin cancer remains the most commonly diagnosed cancer in the United States.
By Lou Valdez MS, Dara Corrigan JD, & Peter Stein MD – Regulatory experts from around the world, including FDA, gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products.
By Scott Gottlieb MD – It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies.
By Stephen Ostroff MD – The FDA is honoring an important commitment by awarding millions of dollars to the states that will help implement the new produce safety rule mandated by the FDA Food Safety Modernization Act (FSMA) to protect consumers from foodborne illness.
By Richard Pazdur MD – I am honored to be selected by Commissioner Califf as the acting director of FDA’s new Oncology Center of Excellence (OCE) in support of the Vice President’s National Cancer Moonshot Initiative.
By Kathleen “Cook” Uhl MD – At FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, 2015 was an important year. It was our first full year of operation after vastly expanding our office’s scope and structure
By Taha A. Kass-Hout MD, MS & Elaine Johanson – Imagine a world where doctors have at their fingertips the information that allows them to individualize a diagnosis, treatment or even a cure for a person based on their genes. That’s what President Obama envisioned when he announced his Precision Medicine Initiative earlier this year.
By Stephen M. Ostroff MD – Last week our nation lost a true pioneer in public health and consumer protection. Frances Oldham Kelsey, Ph.D., M.D., who joined FDA in 1960 as a medical officer, was known worldwide as a leader in drug safety and the protection of patients.