Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations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
On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...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
The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more
This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more
On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada),...more