Keyless Ignitions and the Dangers of Carbon Monoxide Poisoning
Straight Talks: Autonomous regulations around the world
Straight Talks: Innovations in product liability for autonomous and connected vehicles
In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a global supply chain, rapid...more
On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more
We’ve all heard that mercury is poisonous — causes neurological damages, developmental defects, etc. Mercury thermometers have been phased out and replaced with non-mercury ones. But not so with dental amalgam (silver filling...more
On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers...more
On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more
Massachusetts Federal Court In Multi-District Litigation Holds Under Six States’ Laws That Manufacturer Of Brand-Name Pharmaceutical Is Not Liable For Injuries Caused By Generic Equivalents Whose Manufacturers Were Required...more
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more