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 …›

Top 10 Considerations When Drafting and Negotiating SRAs, with U.S. and EU Perspectives

Sponsored Research Agreements (SRA) are used by companies to contract a research organization, such as a university, to conduct research and development activities in exchange for fees and the university’s rights to use the results for general research purposes. Care should be taken to …›

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 …›

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, …›

GSAS Harvard Biotech Club and Morrison & Foerster’s New Course

MoFo & GSAS Harvard Biotech Club’s new course, “Legal Topics for Scientists, Entrepreneurs, and Start Ups,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The Harvard Biotech Club is a student organization that seeks to bridge …›