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FTC Issues Updated Health Products Claims Guidance
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was
Actived: 7 days ago
URL: https://lifesciences.mofo.com/topics/ftc-issues-updated-health-products-claims-guidance
FDA Publishes Digital Health Technology Framework
WEBOn Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
FDA Releases Draft Guidance on Digital Health Technologies for …
WEBSpecial thanks to Morrison & Foerster Regulatory Analyst Brandy Guarda for contributing to this article. In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while mitigating health risks.
FDORA Passage Brings Significant Changes to FDA’s Drug, Device, …
WEBThe Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug, and Cosmetic Act (FDCA) governing drugs, medical devices, and clinical trials, as well as …
FDA on Use of AI/ML in Drug Development: Five Key Takeaways
WEBHere are five key takeaways: 1. FDA Acknowledges that AI/ML Applications Exist for Each Stage of Drug Development. AI/ML may have applications for use in all stages of drug development, from drug discovery to pharmaceutical manufacturing. AI/ML has been applied to real‑world data (RWD) and data from digital health technologies …
EHR Vendor Settles Kickback Allegations to the Tune of $18.25 …
WEBOn January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying impermissible kickbacks related to its electronic health records (EHR) product. At the center of the DOJ’s complaint was Athena’s use of …
Morrison & Foerster Partners Speak at FDLI’s Digital Health …
WEBThe Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021.. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference.
Software as a Medical Device in Europe
WEBThe COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue. As with every health-related product or service, manufacturers of software addressing …
U.S. Government Launches Billion-Dollar Biomedical Agency
WEBU.S. Government Launches Billion-Dollar Biomedical Agency. As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in …
CTA Publishes New Standard for Healthcare AI MoFo Life Sciences
WEBHuman Trust. The Human Trust factors focus on facilitating transparent and smooth human interaction with the product. The standard encourages developers to provide users with clear descriptions of what the AI predicts, its clinical parameters, limitations, and performance parameters.
States Extend Scope of Regulatory Oversight of Health Care Entities
WEBThe proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, health care costs, and access to services. State regulators play a key role in monitoring and challenging anticompetitive behavior at the local level but have varying degrees of …
The Diagnostics Dilemma: Securing and Protecting Diagnostic …
WEBWhile many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine allowing treatment that is customized to a patient’s unique biology, the U.S. Supreme Court dealt a blow to the industry with its decision in Mayo Collaborative Services …
Mental Health during COVID-19: FDA Waivers for Digital Health …
WEBLast week, the U.S. Food and Drug Administration (FDA) announced temporarily waiving certain requirements for digital health devices for treating psychiatric disorders in its Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency …
Category: Food, Coronavirus Go Health
Digitalization of German Healthcare System to Receive Legislative …
WEBDigitalization of German Healthcare System to Receive Legislative Boost in 2024. By: Robert Grohmann and Philip Radlanski. It is no secret that the healthcare system in Germany is not sufficiently digitized. The German Federal Ministry of Health has therefore developed a strategy to digitize and simplify healthcare for the German …
New York Enacts Material Healthcare Transactions Notice …
WEBOn May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare …
Eu Mdr and Ivdr Implementation: New Transitional Regime Enters …
WEBOn March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the European Union. The Regulation provides for highly anticipated extensions of the transition periods under the EU Medical Device Regulation …
Congress Expands FDA Authority Over Cosmetics
WEBThe Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug Administration (FDA) significant new authority to regulate cosmetics. This is the largest expansion of FDA’s …
BIDEN ADMINISTRATION Executive Order on Promoting …
WEBOn July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a comprehensive summary of the efforts to change both the substance and the approach of the federal government to U.S. competition policy.
Recent Updates on Use of Post-filing Data as Evidence to Support
WEBThe submission of post-filing-date data can be a mechanism by which additional evidence in support of patentability can be provided once prosecution has begun. The United States Patent Office (USPTO) has long allowed post-filing-date data in the form of an affidavit or declaration to provide objective evidence to demonstrate non …
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