Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
Summary - Last year the World Intellectual Property Organization (WIPO), under a threat of a vote, accelerated negotiations on an international legal instrument related to intellectual property (IP) and genetic resources...more