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
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 and the third-party entities that service the devices. Wittenberg and Smith explain how the FDA […]
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, Kymriah (tisagenlecleucel), is for certain pediatric and young adult patients with a form of acute […]
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 FDA during the George W. Bush administration, lastly as its deputy commissioner for medical and […]
By Daniel S. Wittenberg, Co-Chair, Medical Device and Pharmaceutical Industry Group On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs” specifically states that in an effort to “manage the costs associated with the […]
By Daniel S. Wittenberg and Tim Scalo[1] On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions[2]. The non-binding draft guidance provides clarity to FDA staff and the medical device industry by setting out the benefit […]
The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, inflammatory bowel diseases and other conditions. Inflectra is a biosimilar to Remicade which has been […]
On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket […]
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand, loss of consumer confidence, harm to the business and trigger potential regulatory consequences as well as result in […]
