As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a
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 10
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…
Is Your Software a Medical Device? FDA Weighs-in with New Draft Guidances
By Jennifer Pike & Yetunde Oni
On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of…
Senate Bill Seeks to Provide “Floor” for Cybersecurity Operational Standards for Internet-Connected Devices Purchased by Federal Agencies
A recent bill introduced by Sen. Mark Warner (D-Va.) is attempting to place heightened security standards on all Internet of Things (IoT) devices procured by any federal agency. Should the legislation be enacted, the expectations it sets forth regarding the…
FDA Guidance Offers Initial Thoughts on Technical Considerations Specific to Medical Devices Using 3D Printing
The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This…
A Complete Victory for Multi-Office Team as the U.S. Department of Justice Dismisses Billion-Dollar False Claims Act Case
On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR…
FDA Finalizes Policy for Sharing Patient-Specific Data from Medical Devices
FDA recently released guidance (“Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request”) finalizing its policy on medical device manufacturers sharing patient-specific information from devices with patients at the patients’ request.
In response to the more…
FDA Withdraws “Compounding Animal Drugs from Bulk Drug Substances” Draft Guidance
The U.S. Food & Drug Administration (“FDA”) announced on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.” FDA confirmed that it does not intend to finalize the current…
Upcoming Free CLE Webinar: “The Internet of Things’ Impact on the Health Care Industry: Diagnosing the Dangers with Disruptive Technology”
By Lisa Baird
Reed Smith not only assists our pharmaceutical and medical device clients with their current legal challenges and opportunities, we look around corners to anticipate the next industry disruptor – and to help our clients navigate the legal issues that come…
Reed Smith Partner Kevin Madagan to Speak at HDA’s Annual DSCSA Traceability Seminar
Washington D.C. Partner Kevin Madagan of Reed Smith’s Life Science Health Industry group will participate in an exert legal panel discussion at the 2017 Health Care Distribution Alliance (HDA) Traceability Seminar held November 8-10 in Washington D.C.
Implementation of the…