On October 25, 2017, FDA released a critical draft guidance on the breakthrough medical device pathway established by the 21st Century Cures Act (the “Cures Act”). The Draft Guidance For Industry, Breakthrough Device Pathway (“Draft Guidance”) reflects FDA’s proposal regarding
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 11
Reed Smith Partner Rachael Pontikes to speak at FDLI’s Drug Quality Security Act Conference
Chicago Partner Rachael Pontikes of Reed Smith’s Life Science Health Industry group will speak at the Food and Drug Law Institute’s (FDLI) Drug Quality Security Act Conference on November 15 in Washington D.C.
The conference will include panels of government…
Philadelphia Life Sciences CLE Day for In-House Counsel: November 2
By Lisa Baird
Reed Smith’s Life Sciences Health Industry Group is proud to be hosting its third annual Life Sciences CLE Day at our Philadelphia office on Thursday, November 2. The day starts with breakfast and networking at 8:30 a.m. and sessions commence…
The FDA Releases Enhanced Regulatory Initiatives for Drug Compounders
On September 26, 2017, FDA Commissioner Scott Gottlieb, M.D. released a statement about FDA’s ramped up regulatory initiatives for drug compounders. These initiatives include: (1) publishing a report that provides a list of all the drugs that outsourcing facilities have…
Upcoming Free CLE Webinar: “3D Printing: Component Parts/Raw Materials Product Liability & Health Risks”
By Lisa Baird
Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into…
FDA Clarifies Trading Partners Under the DSCSA
The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act…
Germany – A Major Hub for Patent Litigation
With the Unified Patent Court now stalled for at least the near future, U.S. life sciences companies will continue to face the question of where to bring patent infringement cases in Europe. The German courts offer a variety of…
Reed Smith Partners to Speak at Upcoming “Women Leaders in Life Sciences Law Conference” – July 20-21
By Lisa Baird
Two members of Reed Smith’s Life Sciences Health Industry (LSHI) group will be speaking at the American Conference Institute’s 4th Annual Conference on Women Leaders in Life Sciences Law taking place in Boston on July 20-21, 2017.
On Thursday, July…
Upcoming Free CLE Webinar: “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”
By Lisa Baird
The Reed Smith life sciences product liability and 3D printing teams will be hosting an upcoming CLE webinar “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8,…
Lessons from the Competition Appeal Tribunal Hearings in Merricks v. MasterCard and Gibson v. Pride Mobility Scooters
The UK held the first two hearings under its new opt-out class action procedure. The precise rules governing UK class actions will be developed over time from the general guidelines in the statute. There are significant similarities between the U.S.…