The European Commission (the “Commission”) wants to “avoid unnecessary administrative and financial burdens for applicants and competent authorities.” As such, the Commission’s proposal for a revised Directive on the Union Code Relating to Medicinal Products for Human Use (the “Directive”) retains the Decentralized Procedure (“DCP”) and Mutual Recognition Procedure (“MRP”). Chapter III of the Directive sets out the new procedures for national marketing authorizations (“MAs”). This includes a purely national MA procedure granted in a single Member State … Read the rest
Yesterday President Biden issued a Proclamation (full text) declaring May to be Jewish American Heritage Month. The Proclamation reads in part:
Jewish Americans continue to enrich every part of American life as educators and entrepreneurs, athletes and artists, scientists and entertainers, public officials and activists, labor and community leaders, diplomats and military service members, public health heroes, and more….
… Read the restAll Americans — including business and community leaders, educators, students, athletes, entertainers, and influencers — must help confront bigotry in all
On April 19, 2023, the influential CDP (formerly known as the Carbon Disclosure Project) announced that nearly 7,000 organizations worldwide can disclose their plastic-related impacts for the first time, as CDP’s global environmental disclosure platform opens for 2023 reporting. CDP is adding plastic-related reporting to its online platform in response to a request from more than 740 investors with US$ 136 trillion in assets.
Last October, CDP reported that a record of around 20,000 organizations (over 18,700 companies representing over half of global market capitalization … Read the rest
This 4/20, patent owners with Intellectual Property (“IP”) related to cannabis have one more reason to celebrate as they may be able to enforce their rights against infringers in federal court. IP rights may provide an enforceable protection against copycats and competitors in the market, and may provide significant value to a company’s balance sheet. This was demonstrated when Tilray Brands, Inc. announced its intent to acquire fellow cannabis company Hexo Corp., a Canadian entity with a large patent portfolio … Read the rest
The Financial Conduct Authority confirmed last month that the limit for compensation that can be awarded by the Financial Ombudsman Service (“FOS”) will be raised from £375,000 to £415,000, for complaints made after 1 April 2023 relating to acts or omissions on or after 1 April 2019 – an increase of over 10%.
A lower limit of £190,000 applies to any complaints made from 1 April 2023 relating to events that occurred prior to 1 April 2019 – again an … Read the rest
When this blogger thinks about the “Big Three” her mind goes to This is Us – Kevin, Kate and Randall. Admittedly, that’s not the only “Big Three.” Most people probably go to Great Britain, the United States, and the Soviet Union in World War II. But that alliance certainly was shorter than the Pearsons. Now, if you want longevity, ABC, CBS, and NBC are referred to as the Big Three in traditional broadcast television. Being the Big Three prior … Read the rest
As our loyal readers know, the blog has been keeping a close eye on plaintiffs’ efforts to apply product liability law to software . This is of course an area of keen interest to medical device, software, and tech companies active or entering the digital health space.
The blog’s own Eric Alexander, with Reed Smith co-authors Gerry Stegmaier, Jamie Lanphear, and Michael Rubayo, has now written a very thorough chapter on this subject for the International Comparative Legal Guides’ fourth … Read the rest
When we see a court dismiss a pharma product liability case on preemption grounds, we simply have to write about it. Otherwise, we’d be required to turn in our bar card, our defense hack card, and our friendly neighborhood DDL blogger card.
In Polson v. AstraZeneca Ltd. Partnership, 2023 WL 2770687 (D.Conn. April 4, 2023), the plaintiff had taken medicine to address constipation caused by opioid pain treatments. She alleged that the anti-constipation medicine caused her to suffer life threatening … Read the rest