By Patrizia Cavazzoni MD – The U.S. Food and Drug Administration regulates biological products, or biologics, which have transformed the treatment of many illnesses and are the fastest-growing class of medications in the U.S. Biologics offer hope and healing to millions of Americans, but they can be expensive.
By Robert M. Califf MD – Recently I marked my one-year anniversary as the 25th Commissioner for Food and Drugs. I have been proud to represent the U.S. Food and Drug Administration and its talented and hard-working staff in these extraordinary times.
By Patrizia Cavazzoni MD – The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research approved a wide variety of safe and effective new therapies in 2022, even as our nation continues to face the COVID-19 pandemic.
The thought leaders in our community are good about sharing their thoughts on the issues of today. Here are the top read and shared guest posts of December that we think deserve sharing again.
By Janet Woodcock MD & Meredith Chuk MD – The U.S. Food and Drug Administration’s responsibilities to protect the public health are broad, complex, and necessary because the products we regulate are in every home and used every day across the U.S.
By Andrea C. Furia-Helms MPH – Patients are at the heart of the U.S. Food Drug Administration’s mission. Understanding patients’ experiences is critical to support medical product regulation and help ensure safe, effective and innovative medical products are available. Learning from patients helps the agency uphold its public health mission.
By RADM Denise Hinton & Tina Morrison PhD – We live in an era of rapidly changing technological advancements that enable science to evolve at an unprecedented pace. At the U.S. Food and Drug Administration, we rely on our scientific and technical experts to make sound, science- and evidence-based regulatory decisions to protect and promote public health.
By Judy McMeekin Pharm D – It has been said that there is good fishing in troubled waters and that has been the case with fraudsters seeking to profit from anxiety and fears associated with COVID-19. Accordingly, the U.S. Food and Drug Administration is on the lookout for charlatans seeking to profit from the pandemic.
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.
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