FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to …›

FDA’s Covid-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›

December 14, 2020 - COVID-19, FDA, Pharma, United States

FDA Authorizes First COVID-19 Vaccine

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and …›

Podcast: Toward a Therapy for COVID-19: The Science and Legal Considerations

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast series, we discuss the science, regulatory framework, and commercial transaction considerations of a COVID-19 therapy. Michael Ward, …›

November 17, 2020 - FDA, Healthcare, United States

Recent Digital Health-Related FDA Announcements

The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, …›

Legal Topics for Scientists, Entrepreneurs, and Start Ups

The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn …›

Podcast: Toward a Vaccine for COVID-19: The Science and Legal Considerations

In this third of a four-part podcast series, we discuss the science, regulatory framework, and commercial transactions considerations of a COVID-19 vaccine. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with: …›