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.
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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.
By Anna Abram & Mark Abdoo – The European Union (EU) is one of the U.S. Food and Drug Administration’s most important collaborators in tackling public heath challenges. The FDA and the European Commission (EC) and its European Medicines Agency (EMA) have long leveraged each other’s expertise and experience…
By Stephen M. Hahn MD – One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.
By Anand Shah MD & Jeff Shuren MD – As we at the FDA have said before, every step we have taken in our approach to COVID-19 testing has been a careful balancing of risks and benefits – all done to anticipate and meet continuing and evolving public health needs as we combat this virus.