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Snell & Wilmer Product Liability Group
Experienced trial attorneys. Trusted advisors. Counseling companies across the country and throughout their products' lifecycles.
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FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar
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, … Continue reading
Posted in biosimilar, FDA, pharmaceutical
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FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements
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) … Continue reading
Posted in FDA, guidance, medical devices
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Adopting a Safety Policy and Assembling a Safety Team
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 … Continue reading
Posted in medical devices
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FDA Issues Draft Guidance on Distributing New Risk Information for Approved Drugs and Biologics
In June 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the distribution of new risk information for approved prescription drugs to healthcare professionals and healthcare entities. The draft guidance, entitled Guidance for Industry Distributing Scientific … Continue reading
Posted in FDA, pharmaceutical
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FDA Issues New Draft Guidance on Medical Device Data Systems
On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical … Continue reading
Summary of FDA’s Final Guidance on Dear Health Care Provider Letters
At the beginning of this year, the Food and Drug Administration (FDA) issued its final guidance on the content and format of Dear Health Care Provider (DHCP) letters. DHCP letters are correspondence, often in the form of a mass mailing … Continue reading
Posted in consumer products, FDA, guidance, medical, pharmaceutical, Uncategorized
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Summary of FDA Guidance on Mobile Medical Apps
Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps will be … Continue reading
Posted in FDA, guidance, medical, medical devices, mobile
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