FDA Issues Draft Guidance on Remanufacturing

Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the … Continue reading

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Update on FDA Guidance Pertaining to COVID Variants

As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. … Continue reading

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Virginia Legalizes Marijuana

Virginia lawmakers approved a bill this past weekend that would legalize the sale and recreational use of marijuana beginning in 2024. The move makes Virginia the first Southern state to vote to legalize recreational marijuana, joining 15 other states and … Continue reading

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FDA Releases New Guidance for Covid-19 Products

At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In … Continue reading

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FDA Provides Coronavirus Testing Update

FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There … Continue reading

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Data Privacy: More Than Just “The New Black”

Check out Dan Wittenberg’s article on Data Privacy in the Spring 2020 edition of Litigation News – https://www.americanbar.org/groups/litigation/publications/litigation-news/business-litigation/data-privacy-more-just-new-black/ @SWlawnews @abalitigation #cobioscience @cobioscience

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Seven Snell & Wilmer product liability attorneys recognized as leaders in Product Liability Litigation – Defendants by The Best Lawyers in America 2020

Snell & Wilmer recently announced that 143 of the firm’s attorneys were selected by their peers for inclusion in The Best Lawyers in America©. Of those attorneys, seven partners were recognized in the practice area of Product Liability Litigation – … Continue reading

Posted in automotive, CPSC, FDA, litigation, medical devices, products

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Snell & Wilmer Attorneys Publish Article on Medical Device Servicing and Remanufacturing

Denver partner Dan Wittenberg and associate Kelly Smith recently published an article, “Clarifying the Difference Between Medical Device Servicing and Remanufacturing,” in DRI’s For the Defense. The article explores the longstanding divide in the medical device industry between device manufacturers … Continue reading

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FDA Makes Gene Therapy Available for First Time in USA

Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the FDA. The product, … Continue reading

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Senate Confirms New FDA Commissioner

Dr. Scott Gottlieb was confirmed today as the new FDA Commissioner.  Dr. Gottlieb has promised to put public health first and not do anything “that shakes the public’s confidence in the agency.” He is a former hospitalist who served in the … Continue reading

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