Following up the success of its first, medical device-focused 3D printing white paper, 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, Reed Smith’s 3D Printing Task Force has now launched a second
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 13
MDR Reporting Final Guidance
By Lisa Baird
FDA issued a final guidance on November 8, 2016, “Medical Device Reporting for Manufacturers”. As with all such guidance documents, it is nonbinding: “It does not establish any rights for any person and is not binding on FDA…
CMS Finalizes Two-Track System to Implement Significant Changes in Medicare Physician Payment Policies Under MACRA
The Centers for Medicare & Medicaid Services (CMS) has finalized sweeping reforms of the Medicare physician fee schedule (MPFS) update framework, as mandated by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Beginning in 2017, physicians can…
Significant Changes for Long-Term Care Facilities Participating in Medicare and Medicaid Programs Issued by CMS
The Centers for Medicare & Medicaid Services (CMS) issued a final rule on September 28, 2016, comprehensively updating and extensively revising the requirements for participation (ROPs) for long-term care (LTC) facilities participating in the Medicare and Medicaid programs (the Final…
Philadelphia Life Sciences CLE Day for In-House Counsel: November 10
By Lisa Baird
Reed Smith’s Life Sciences Health Industry Group is hosting a Life Sciences CLE Day at our Philadelphia office on Thursday, November 10. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event,…
Please Join Us For Our Annual “12 Months in Health Care Law: A Roller Coaster Journey” Webinar
By Lisa Baird
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner…
Join Us for a Free CLE Webinar on Social Media Issues for Pharmaceutical, Medical Device Companies
By Lisa Baird
The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to…
Reed Smith Attorneys to Speak at DRI’s November 10th Government Enforcement and Corporate Compliance Seminar
By Lisa Baird
Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar.
This panel will examine recent…
OIG Encourages CMS Claim Forms Which Will Allow For Better Tracking Of Implantable Medical Devices
By Lisa Baird
On September 30, 2016, the Department of Health and Human Service’s Office of the Inspector General (OIG) issued an “Early Alert” to the Centers for Medicare & Medicaid Services (CMS) on “Incorporating Medical Device-Specific Information on Claim Forms”. This…
European Patent Litigation for Life Sciences Companies: a Silver Lining to the Brexit Cloud?
The introduction of the Unified Patent Court (UPC) is undoubtedly the most significant change to the European patent landscape since the European Patent Convention of 1973. It will have a profound effect on how life sciences companies set about their…