As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. In an update to its guidance on EUAs for COVID-19 vaccines, the FDA details the […]
Virginia lawmakers approved a bill this past weekend that would legalize the sale and recreational use of marijuana beginning in 2024. The move makes Virginia the first Southern state to vote to legalize recreational marijuana, joining 15 other states and the District of Columbia. Per the bill that passed, possession of up to an ounce […]
At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In a recent article, acting FDA Commissioner Janet Woodcock is noted as saying “[t]he purpose of […]
FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular […]
Under current United States Supreme Court precedent, for a court to exercise personal jurisdiction over a manufacturer like Ford, the plaintiff must demonstrate that the court has either general or specific jurisdiction. General jurisdiction is only established where the defendant’s connection to the forum state is so systematic and continuous that the defendant is considered […]
On September 18, 2020, Governor Gavin Newsom (D) signed Senate Bill (“S.B.”) 1146 into law. This act was aimed at amending Sections 1010.6 and 2025.310 of the California Code of Civil Procedure, and to add and repeal Section 599. These sections of Code of Civil Procedure govern discovery deadlines, methods for service, mandatory settlement conferences, […]
Check out Dan Wittenberg’s article on Data Privacy in the Spring 2020 edition of Litigation News – https://www.americanbar.org/groups/litigation/publications/litigation-news/business-litigation/data-privacy-more-just-new-black/ @SWlawnews @abalitigation #cobioscience @cobioscience
On November 21, 2019, the National Highway Traffic Safety Administration (“NHTSA”) released nine draft test procedures intended to help evaluate certain types of Advanced Driver Assistance Systems (“ADAS”). NHTSA is seeking public comment regarding the adequacy of these test procedures by January 21, 2020. The draft procedures are research-focused, with NHTSA intending to “research ways […]
In Gavaldon v. DaimlerChrysler Corp. (2004) 32 Cal. 4th 1246, the California Supreme Court found that service contracts are not express warranties under the Song-Beverly Consumer Warranty Act and the Act did not otherwise authorize replacement or restitution as a remedy for breaches of service contracts. The Song-Beverly Consumer Warranty Act, Civil Code section 1791 […]
In Monster Energy Co. v. Schechter, 7 Cal.5th 781, 792 (2019) the California Supreme Court was tasked with determining “whether counsel’s signature approving a [settlement] agreement as to form and content for his clients’ signature precludes, as a matter of law, a finding that he also intended to be bound by the agreement.” The Court […]
