In France, transparency requirements are regulated by two main sets of laws: “The French Anti-Gift Law” regulates the provision of gifts, discounts and other incentives to health care providers by life sciences companies, while “the French Sunshine Act” imposes disclosure
Life Sciences Legal Update
Analysis & commentary by Reed Smith on trends & developments in life sciences & health care law
Life Sciences Legal Update, published by Reed Smith LLP, focuses on legal developments affecting multinational and global life sciences companies. The blog covers topics such as regulatory guidance from agencies like the FDA, product recalls, patent law issues including AI inventorship, and compliance with evolving healthcare and pharmaceutical regulations. It also addresses litigation trends, industry-specific legislative changes, and risk management strategies relevant to drug and medical device manufacturers. The blog serves as a resource for legal professionals and industry stakeholders seeking updates on the intersection of law and life sciences business operations.
Latest from Life Sciences Legal Update - Page 12
Final Rule on Amending the Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules on Beneficiary Inducements
On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP) rules prohibiting beneficiary inducements.…
Unified Patent Court Could be Operational as Early as December 2017
As we discussed in a prior post, the introduction of the Unified Patent Court (UPC) will be a significant change to the European patent landscape and will have a profound effect on how life sciences companies set about their…
Revised International Enforcement Guidelines Prescribe Increasing Collaboration Between U.S., Foreign Competition Agencies to Investigate, Prosecute Antitrust Violations
Companies, including those in the pharmaceutical and medical device industries, with multinational operations should expect increasing collaboration between U.S. and foreign competition agencies to investigate and prosecute alleged antitrust violations. In light of recent and ongoing investigations by U.S. and…
Upcoming Free CLE Webinar: Hosting and Managing User Generated Content (UGC)
By Lisa Baird
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “Hosting and Managing User Generated Content (UGC)” on Thursday, January 19, 2017 at 12 p.m. ET. This webinar will address the legal liability and…
FDA Advances LDT Dialogue with New Discussion Paper Containing Updated CMS/FDA Oversight Proposal
On January 13, 2017, the Food and Drug Administration (FDA) released a discussion paper concerning an updated proposed framework for oversight of laboratory developed tests (LDTs). According to FDA, the updated proposal is the result of ongoing engagement with industry…
Join Us: Free CLE Webinar on Best & Worst Drug/Medical Device Decisions of 2016
By Lisa Baird
Reed Smith’s Life Sciences Health Industry Group will be hosting an upcoming CLE webinar, “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on Wednesday, January 18, 2017 at 12 p.m. …
Radiopharmacies Celebrate the New Year with Long-Awaited FDA Guidance
On December 29, 2016, the U.S. Food and Drug Administration (“FDA”) surprised many in the radiopharmacy industry by issuing a long-awaited draft guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance addresses conditions under…
Key Provisions of 21st Century Cures Act – Interest to Drug/Device Clients
By Lisa Baird
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). It is hoped that provisions in the new bill, and the $6.3 billion it provides for medical research over the next decade, will…
FDA Consumer Update: The 3Rs of 3D Printing – FDA’s Role
On December 21, 2016, the U.S. Food and Drug Administration (“FDA”) posted a Consumer Update and accompanying video on the “The 3Rs of 3D Printing: FDA’s Role,” which reconfirms its position on the importance of 3D printed medical devices. The…