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Articles by Kellie Combs
Black boxes, white coats and red tape: Regulating the use of AI in drug development | JD Supra
AI systems are being used throughout the medicines lifecycle to analyse large volumes of data. These systems often rely on complex, opaque model architectures that autonomously train on large data sets, presenting unique risks. The actual risk posed by an AI system depends on the specific context of its use and the extent to which it impacts decision-making.
Navigating the Future: 2026 Life Sciences Regulatory Outlook – Global Strategies for Tackling Escalating Cross-Border Challenges | JD Supra
On 20 January 2026, Ropes & Gray’s Global Life Sciences Regulatory & Compliance team hosted the “Life Sciences Regulatory Outlook 2026” webinar. The session provided actionable insights into the most significant regulatory, compliance, and enforcement developments shaping the life sciences sector worldwide.
EXPERT INSIGHTS- RARE DISEASE FOCUS: FDA'S TRIO OF CELL AND GENE THERAPY DRAFT GUIDANCES HIGHLIGHT EXPEDITED PROGRAMS, INNOVATIVE TRIAL DESIGNS, AND POSTAPPROVAL EVIDENCE GENERATION | Secondary Sources | National | Westlaw Today
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Rare Disease Focus: FDA's Trio Of Cell And Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs, And Postapproval Evidence Generation
RG Ropes & Gray LLP More Ropes & Gray is a preeminent global law firm with approximately 1,400 lawyers and legal professionals serving clients in major centers of business, finance, technology and government. The firm has offices in New York, Washington, D.C., Boston, Chicago, San Francisco, Silicon Valley, London, Hong Kong, Shanghai, Tokyo and Seoul.
Non-binding Guidance: The Administration's Focus On Direct-to-Consumer Prescription Drug Advertising (Podcast)
In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray's life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair of Ropes & Gray's life sciences regulatory and compliance practice group, to discuss the Trump administration's recent crackdown on direct-to-consumer (DTC) prescription drug advertising.
Non-binding Guidance: The Administration’s Focus on Direct-to-Consumer Prescription Drug Advertising | JD Supra
In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray’s life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair of Ropes & Gray’s life sciences regulatory and compliance practice group, to discuss the Trump administration’s recent crackdown on direct-to-consumer (DTC) prescription drug advertising.
The Administration Targets Direct-To-Consumer Prescription Drug Advertising
On September 9, 2025, the U.S. Food and Drug Administration ("FDA") issued a Press Release announcing a "crackdown on deceptive drug advertising." Concurrently, the U.S. Department of Health and Human Services ("HHS") published a Fact Sheet with further detail on FDA's reforms as well as a Press Release on potential FDA rulemaking.
The Administration Targets Direct-to-Consumer Prescription Drug Advertising | JD Supra
On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) issued a Press Release announcing a “crackdown on deceptive drug advertising.” Concurrently, the U.S. Department of Health and Human Services (“HHS”) published a Fact Sheet with further detail on FDA’s reforms as well as a Press Release on potential FDA rulemaking.
The administration targets direct-to-consumer prescription drug advertising
(October 01, 2025) - Ropes & Gray attorneys Kellie Combs, Greg Levine, Joshua Oyster and Pascale Stain discuss the federal government's push to increase scrutiny of direct-to-consumer prescription drug advertising.
Insights from the Third Annual Ropes & Gray Rare Disease Forum | JD Supra
Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to explore ongoing regulatory reforms, policy change, legal developments, and shifts in compliance and enforcement risks as we passed the first 100 days of the new administration.
EXPERT INSIGHTS-FDA ISSUES DRAFT GUIDANCE DESCRIBING WHEN A CONFIRMATORY TRIAL OF A DRUG SEEKING ACCELERATED APPROVAL IS 'UNDERWAY'
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FDA Issues Draft Guidance Describing When A Confirmatory Trial Of A Drug Seeking Accelerated Approval Is "Underway"
In recent years, Congress and the U.S. Food and Drug Administration ("FDA") have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic benefit to patients over existing treatments for serious or life-threatening illnesses or conditions.
FDA Issues Draft Guidance Describing When a Confirmatory Trial of a Drug Seeking Accelerated Approval Is “Underway” | JD Supra
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic benefit to patients over existing treatments for serious or life-threatening illnesses or conditions.
FDA Finalizes Guidance On Communication Of Scientific Information On Unapproved Uses And Releases Updated First Amendment Analysis
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers ("SIUU Final Guidance"). The SIUU Final Guidance updates an October 2023 draft guidance of the same name, which we described in a prior Alert and podcast.
FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis | JD Supra
On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers (“SIUU Final Guidance”). The SIUU Final Guidance updates an October 2023 draft guidance of the same name, which we described in a prior Alert and podcast.
Non-Binding Guidance: How Drug And Device Companies Can Tackle Internet Misinformation (Podcast)
On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray's life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA's revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA's prior draft guidance, potential challenges in implementing...
Decoding Digital Health: AI/ML Webinar Recap-U.S. FDA & European Perspectives
Click here to listen to the audio. On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, host Kellie Combs, a partner in the life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group, is joined by Greg Levine, chair of the firm's global life sciences regulatory and compliance practice, and Lincoln Tsang, head of the European life sciences practice.
Non-Binding Guidance: Preview Of The Second Annual Ropes & Gray Rare Disease Forum (Podcast)
In honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024.
Non-binding Guidance: Preview of the Second Annual Ropes & Gray Rare Disease Forum
Click here to listen the audio In honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024.
U.S. Life Sciences Regulatory And Compliance Outlook 2024 (Part II): Product Development And Pricing (Podcast)
Join Ropes & Gray's life sciences and health care attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this second episode, we focus on key issues to watch related to product development, approval, and drug pricing in 2024.
U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part III): Advertising and Promotion
Please click here to listen to the audio Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this third episode, life sciences regulatory and compliance partners Kellie Combs and Josh Oyster discuss key developments and trends related to medical product advertising and promotion.
First Circuit Affirms Convictions Of Former Acclarent Executives Related To Off-Label Promotion Of Medical Device
On December 14, 2023, the U.S. Court of Appeals for the First Circuit issued a long-awaited opinion affirming the convictions of William Facteau and Patrick Fabian, former executives of Acclarent, on misdemeanor adulteration and misbranding charges under the Federal Food, Drug, and Cosmetic Act ("FDCA") related to their involvement in the off-label promotion of a medical device.
First Circuit affirms convictions of former Acclarent executives related to off-label promotion of medical device
(January 3, 2024) - Ropes & Gray attorneys Kellie Combs, Douglas Hallward-Driemeier, Joshua Oyster and Beth Weinman discuss a decision affirming two former medical device company executives' convictions, calling it "the most significant court ruling related to off-label speech in nearly a decade." On December 14, 2023, the U.S. Court of Appeals for the First Circuit issued a long-awaited opinion affirming the convictions of William Facteau and Patrick Fabian, former executives of Acclarent,...
First Circuit Affirms Convictions of Former Acclarent Executives Related to Off-Label Promotion of Medical Device
On December 14, 2023, the U.S. Court of Appeals for the First Circuit issued a long-awaited opinion affirming the convictions of William Facteau and Patrick Fabian, former executives of Acclarent, on misdemeanor adulteration and misbranding charges under the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to their involvement in the off-label promotion of a medical device.
Reading The Fine Print On FDA's Prescription Drug Ad Rule
ADVERTISEMENT Don't want ads? Subscribe or login now. By Kellie Combs, Joshua Oyster and Jessica Band (December 8, 2023, 6:00 PM EST) -- On Nov. 21, the U.S. Food and Drug Administration published a long-awaited final rule that amends the agency's prescription drug advertising regulations. ... A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.
Reading The Fine Print On FDA's Prescription Drug Ad Rule
ADVERTISEMENT Don't want ads? Subscribe or login now. By Kellie Combs, Joshua Oyster and Jessica Band (December 8, 2023, 6:00 PM EST) -- On Nov. 21, the U.S. Food and Drug Administration published a long-awaited final rule that amends the agency's prescription drug advertising regulations. ... A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.
Non-Binding Guidance: FDA's Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products (Podcast)
This installment of Ropes & Gray's podcast series Non-binding Guidance focuses on FDA's recently issued draft guidance, "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers." In this episode, hear from Kellie Combs, Josh Oyster, and Sarah Blankstein, industry-leading attorneys from Ropes & Gray's life sciences regulatory and compliance team, as they delve into FDA's new draft...
Non-binding Guidance: FDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products
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Try, Try Again: FDA Issues Draft Guidance On Communication Of Scientific Information On Unapproved Uses Of Medical Products
On October 23, 2023, the Food and Drug Administration ("FDA") released a draft guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers" ("SIUU Draft Guidance"). The SIUU Draft Guidance provides recommendations for dissemination and discussion of off-label reprints, clinical practice guidelines, and reference texts, among other sources.
Try, try again: FDA issues draft guidance on communication of scientific information on unapproved uses of medical products
(November 7, 2023) - Ropes & Gray attorneys Kellie Combs, Gregory Levine, Joshua Oyster and Sarah Blankstein discuss the Food and Drug Administration's new industry draft guidance for disseminating scientific information on unapproved uses of approved or cleared medical products.
Try, Try Again: FDA Issues Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products
On October 23, 2023, the Food and Drug Administration (“FDA”) released a draft guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers” (“SIUU Draft Guidance”). The SIUU Draft Guidance provides recommendations for dissemination and discussion of off-label reprints, clinical practice guidelines, and reference texts, among other sources.
FTC issues new endorsement guides in advertising
(October 10, 2023) - Peter Brody, Kellie Combs, Cassandra Roth and Meredith Foor of Ropes & Gray discuss the Federal Trade Commission's revised Guides Concerning the Use of Endorsements and Testimonials in Advertising, which had not been updated since 2009. On July 26, 2023, the Federal Trade Commission's (FTC) revised Guides Concerning the Use of Endorsements and Testimonials in Advertising (Endorsement Guides) went into effect.
FDA publishes draft guidance on prescription drug use-related software
(October 6, 2023) - Ropes & Gray attorneys Kellie Combs, Joshua Oyster, Sarah Blankstein, and Jessica Band discuss the Food and Drug Administration's new draft guidance on regulating medication sponsors' software relating to prescription drugs or biological drug products. On September 18, 2023, the U.S. Food and Drug Administration ("FDA") issued a draft guidance for industry entitled Regulatory Considerations for Prescription Drug Use-Related Software1 (the "PDURS Draft Guidance").
U.S. Life Sciences Outlook 2023 (Part IV): Additional Insights on Expected Developments
Click here to listen to the audio. Join Ropes & Gray’s life sciences and health care attorneys on a four-part podcast series exploring regulatory, compliance and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2023. This fourth episode will feature a lightning round where we cover additional insights on expected developments not covered earlier in the series.
U.S. Life Sciences Outlook 2023 (Part III): Agency Litigation Challenges
Click here to listen to the audio Join Ropes & Gray’s life sciences and health care attorneys on a four-part podcast series exploring regulatory, compliance and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2023. This third episode will focus on what we except to see in the courts throughout 2023. Topics discussed include litigation challenges against the agencies, enforcement litigation by the government and other matters.
U.S. Life Sciences Outlook 2023 (Part II): Anticipated Agency Policy Developments
Click here to listen to the audio Join Ropes & Gray’s life sciences and health care attorneys on a four-part podcast series exploring regulatory, compliance and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2023. This second episode will focus on anticipated policy developments from FDA and CMS in 2023.
U.S. Life Sciences Regulatory Outlook 2023 (Part I): 2022 Trends Expected to Continue Into 2023
Click here to listen to the audio This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul.
Non-binding Guidance: Key Takeaways From FDA's Final Guidance On Clinical Decision Support Software (Podcast)
This episode of Ropes & Gray's podcast series Non-binding Guidance examines FDA's final guidance on Clinical Decision Support ("CDS") software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA's approach to CDS software regulation from the agency's 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance.
A Cross-Border Look at the Future of Artificial Intelligence in Life Sciences
Artificial intelligence-enabled technology tools are capable of dissecting large quantities of data faster than ever before and in some cases, in real time. However, the increasingly widespread use of AI challenges regulators to balance the benefits of innovation while protecting patient safety, health and privacy rights.
Podcast: Non-Binding Guidance: FDA Regulatory Developments In AI And Machine Learning
To print this article, all you need is to be registered or login on Mondaq.com. This installation of Ropes & Gray's podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence ("AI") and machine learning.
Digital Health 2021: Trends in Big Data, AI, Telehealth, and Beyond
This was a year unlike any other as the world responded to the pandemic public health emergency by deploying telehealth solutions to comply with social distancing orders and fast-tracked development and deployment of diagnostics, therapeutics, and Covid-19 vaccines. As we move into 2021, we expect big data collaborations and analysis through artificial intelligence (AI) to continue fostering innovation in clinical decision support (CDS) software, patient treatment, and pharmaceutical research.
Digital Health 2021: Trends in Big Data, AI, Telehealth, and Beyond
This was a year unlike any other as the world responded to the pandemic public health emergency by deploying telehealth solutions to comply with social distancing orders and fast-tracked development and deployment of diagnostics, therapeutics, and Covid-19 vaccines. As we move into 2021, we expect big data collaborations and analysis through artificial intelligence (AI) to continue fostering innovation in clinical decision support (CDS) software, patient treatment, and pharmaceutical research.
2 Major Digital Health Trends Driven By COVID-19
By Megan Baca, Kellie Combs and Christine Moundas Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.
Digital Health Download (October 9, 2020)
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Podcast: COVID-19: Non-binding Guidance: Real-World Evidence In Drug Development And The Impact Of The Pandemic - Coronavirus (COVID-19) - United States
To print this article, all you need is to be registered or login on Mondaq.com. The eleventh installment of Ropes & Gray's podcast series, Non-binding Guidance, focuses on the current regulatory landscape surrounding the use of real-world evidence in drug development and the impact of the COVID -19 pandemic. Over the course of the COVID-19 pandemic, there has been an increase in reliance on real-world data and real-world evidence by FDA and other regulatory authorities, as well as industry.
Digital Health Download - Food, Drugs, Healthcare, Life Sciences - United States
Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice): Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below. Mondaq has a "free to view" business model.
Podcast: Non-Binding Guidance: FDA Regulatory And Patent Implications Of The Transition Provision Of The Biologics Price Competition And Innovation Act - Intellectual Property - United States
To print this article, all you need is to be registered or login on Mondaq.com. The ninth installment of Ropes & Gray's podcast series, Non-binding Guidance, focuses on changes to the FDA regulation of certain products pursuant to the "Deemed to be a License" provision, also known as the transition provision, of the Biologics Price Competition and Innovation Act (BPCIA).
FDA-FTC Biosimilar Push Clarifies Antitrust Stance
Law360 (February 19, 2020, 5:42 PM EST) -- On Feb. 3, the U.S. Food and Drug Administration and the Federal Trade Commission announced a collaboration to promote biosimilar competition. The two agencies issued a joint statement outlining goals for the collaboration, which includes sponsoring a public workshop to hear from industry and other stakeholders.
Podcast: Non-Binding Guidance: SEC Disclosure Issues For Life Sciences Companies
The eighth installment of Ropes & Gray's podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development.
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