By Janet Woodcock MD – The U.S. Food and Drug Administration’s Devices Program is responsible for the regulation and oversight of a wide range of medical devices that patients and their health care providers use every day.Read More
By Janet Woodcock MD – The U.S. Food and Drug Administration’s mission to protect and promote the public health impacts the life of every American, every day. Our work encompasses an ever-widening array of foods, additives, cosmetics, medicines, and medical devices as the FDA regulates approximately 20 cents of every dollar spent annually by American consumers.
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 April that we think deserve sharing again.
By Jeff Shuren MD JD & Ed Margerrison PhD – Progress in science and technology offers extraordinary opportunities to develop innovative medical products that can save lives and lead to better treatments, better diagnostics and better care for patients.
By Jeff Shuren MD JD & Daniel Caños PhD MPH – Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and effectiveness of medical devices, assuring that patients have timely access to them, and advancing medical device innovation.
By Janet Woodcock MD & Amy Abernethy MD PhD – With the near ubiquity of interconnected smartphones and computers in modern life, it can be difficult to remember just how quickly our familiarity with data has evolved. Data, in digital form, seem to be everywhere we look.
By Amy Abernethy MD, PhD & Vid Desai – FDA’s Technology Modernization Action Plan accelerates the path to enhancing and promoting “People First” public health.
By Stephen M. Hahn MD & Anand Shah MD – Americans may be surprised to learn that many 21st century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an emergency, and contribute to the high cost of medical products.
By Stephen M. Hahn MD, Patrizia Cavazzoni MD, & Peter Marks MD, PhD – When the U.S. Food and Drug Administration learned of the novel coronavirus (COVID-19) and its potentially devastating effects, we acted swiftly to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease.