After more than 10 years providing updates on a range of topics impacting multinational and global life sciences companies, we’ve made the decision to wind down our Life Sciences Legal Update blog. While the content currently on the blog will still be available to access online in the immediate future, no new content will be
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
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Latest from Life Sciences Legal Update
EU unveils roadmap for EU pharmaceutical strategy
On 2 June, the European Commission (Commission) published a roadmap (Roadmap) that will pave the way for the Commission’s communication on the EU pharmaceutical strategy, which is now due in the last quarter of 2020. The Roadmap should be read together with the Commission’s proposal for a recovery of the EU’s economy (…
FDA Presents Webinar on Technical Considerations for Additive Manufactured Medical Devices
On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to…
U.S.-EU Safe Harbor Framework for Data Sharing
By Lisa Baird
Exactly one month after the Court of Justice of the European Union (CJEU) released its judgment in Maximillian Schrems v Data Protection Commissioner (C-362-14), the European Union released a Communication discussing the implications of their decision on data sharing involving personal information.
This topic is no stranger to the blog, as we’ve posted about…
U.S. Supreme Court Strikes Down Vermont Ban on Data Mining; Rules that State Law Interferes with Drug Makers’ Right to Free Speech
By Lisa Baird
Today, in a 6-3 decision, the U.S. Supreme Court handed down a verdict in Sorrell vs. IMS Health, striking, on free speech grounds, a 2007 Vermont law that that bans the practice of data mining unless a physician specifically gives his or her permission to use the information. Reed Smith filed an amicus brief…
House Energy & Commerce Drug Safety Hearing Set for March 10
By Lisa Baird
As reported by our sister site, Health Industry Washington Watch, on Wednesday the House Energy and Commerce Health Subcommittee will hold a hearing entitled, “Drug Safety: An Update from the FDA.” At the hearing, the FDA will detail its current challenges and successes in the area of drug safety. Joshua M. Sharfstein, M.D., FDA Principal…
White House Announces Funding for Medical Tort Reform Demonstration Projects
By Lisa Baird
On September 17, 2009, the White House released a “Patient Safety and Medical Liability Reform Demonstration” Fact Sheet, which outlines a new $25 million Department of Health and Human Services initiative designed to help states and health care systems identify new models for managing medical liability claims. The three-pronged initiative will support competitive grants to…
Supreme Court Confirms Twombly’s Tighter Pleading Standards Have Broad Application
By Lisa Baird
Yesterday, May 18th, the United States Supreme Court issued Ashcroft, Former Attorney General v. Iqbal, and confirmed the pleading standards it announced in Bell Atlantic Corp. V. Twombley, 550 U. S. 544 (2007), an anti-trust case. Although Ashcroft also dealt with other significant legal issues, it is quite possible that its broadest impact will come…
Wyeth v. Levine Decided
By Lisa Baird
Today the Supreme Court affirmed (http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf) Wyeth v. Levine, as reported by Drug and Device Law.…
California Supreme Court On The Consumer Legal Remedies Act
By Lisa Baird
UPDATE: After more than two years, on February 3, 2009, the California Supreme Court finally set argument in an important UCL case, In re Tobacco II for Tuesday, March 3, 2009, at 9:00 a.m., in San Francisco. With the Court’s 90-day rule, a decision can be expected by June 1, 2009 in the ordinary…