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…Read More
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.
By Scott Gottlieb MD & Gerald Dal Pan MD, MHS – The US FDA is an information-driven agency that requires robust data to make regulatory decisions. One of our key obligations is to analyze large quantities of data related to the safety and effectiveness of medical products…
By Anna Abram & Mark Abdoo – Even in this modern era, when so much can be done remotely, there are many tangible benefits to having “boots on the ground” when doing business overseas. That’s the thinking behind the FDA’s foreign offices, which play a vital role in inspecting….
By Scott Gottlieb, MD, Jeff Shuren, MD, JD, & Michelle Tarver, MD, PhD – Collaboration. It’s a word we use a lot at the FDA — and for good reason. Collaboration is an essential element of many approaches we apply to achieve our public health mission.