In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization one year ago overturned 50 years of legal precedent protecting the constitutional right to abortion in the United States, leaving the question of...more
Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green.
On both sides of...more
9/22/2021
/ Artificial Intelligence ,
Digital Health ,
EU ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Life Sciences ,
Machine Learning ,
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Proposed Regulation ,
Regulatory Oversight ,
Webinars
On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more