FDA’s Technology Modernization Action Plan
By Amy Abernethy MD, PhD & Vid Desai – FDA’s Technology Modernization Action Plan accelerates the path to enhancing and promoting “People First” public health.
Read MoreBy Amy Abernethy MD, PhD & Vid Desai – FDA’s Technology Modernization Action Plan accelerates the path to enhancing and promoting “People First” public health.
Read MoreBy 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.
We’ve rounded up some of the latest news and announcements pertaining to the coronavirus and the healthcare industry.
By Amy Abernethy, MD, PhD & Suzanne B. Schwartz, MD, MBA – Medical devices are increasingly more advanced and interconnected, sharing information via Wi-Fi, the internet, our phones and across hospital networks.
By Janet Maynard, MD & Andrea Furia-Helms – There are approximately 7,000 rare diseases affecting an estimated 30 million people in the United States. Many of these diseases are serious or life-threatening and it is estimated that half affect children.