The Food and Drug Administration on March 4 issued new guidance for voluntary recalls of biologics, drugs, devices, and other products. The guidance finalizes an April 2019 draft that advised how firms in a distribution chain can prepare when conducting
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
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Join Us: Free CLE Webinar on the Best & Worst Drug/Medical Device Decisions of 2021
It’s that time of year again! The Reed Smith bloggers from the Drug and Device Law Blog will be hosting their annual CLE webinar, “The good, the bad, the ugly: the best and worst prescription drug/medical device decisions of 2021”…
Health care workers and private employees could be affected by new CMS interim final rule and OSHA final rule
On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule that requires vaccinations for certain health care workers. The rule is limited to only those entities who are surveyed by CMS and have…
Please Join Us: European Life Sciences Legal Insights Month: 4 – 8, 27 October
Reed Smith will be presenting a virtual webinar series highlighting the numerous regulatory, litigation and transactional changes occurring in the European life sciences industry during the month of October. Our skilled life sciences team – joined by in-house counsel and…
Here we go again – Unified Patent Court back on track
The German Constitutional Court issued a landmark decision with implications for many companies doing business in Europe on July 9, 2021. For decades, the European Commission and EU member states strived to create a pan-European Unified Patent Court (UPC). After…
German Patents Act (PatG) Receives New Updates
Germany recently passed a reform bill for the Patent Act (PatG) and its new provisions will likely be coming into force sooner rather than later. The reform is particularly relevant for companies from the life sciences sector, which often litigate…
A multi-agency pharmaceutical task force looks to review antitrust issues that arise during mergers and acquisitions
A task force, composed of key antitrust enforcement agencies including the Federal Trade Commission (FTC), and the Canadian Competition Bureau, is seeking information from the public regarding the effects of pharmaceutical mergers. This information will be used to update the…
Join Us: Virtual Life Sciences CLE Week for In-House Counsel: November 9-13
Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of interest to our pharmaceutical, biotech, and medical device clients. Sessions include:
- The ABCs of an MDL:
…
Join Us for a CLE Webinar on Strategies for Addressing Common, but Seldom Discussed, Mass Tort Litigation Irritants
As part of the Greater Philadelphia chapter of the Association of Corporate Counsel’s Litigation Law CLE Week, I am pleased to be joining my Reed Smith colleague Jim Beck and Endo Pharmaceuticals’ Vice President and Assistant General Counsel – Litigation…
Please join us for an upcoming CLE webinar, “Preparing for the inevitable: FCA investigations in a post-COVID world”
The CARES Act funding was a lifeline for many health care organizations and life sciences companies, but came with significant attached strings. Related fraud charges are already making headlines and bring with them the serious risk of False Claims Act…