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Food and Drug Administration (FDA) Telemedicine Pharmaceutical Industry

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

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On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more

Alston & Bird

Health Care Week in Review | HHS and DEA Postpone Final Telemedicine Rule; HHS Continues Defense of 340B Rebate Model Authority

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers

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Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 6, October 2024

Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

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Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Wilson Sonsini Goodrich & Rosati

Off-Label Communications Back in the Spotlight at the FDA

For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more

Foley & Lardner LLP

FDA Issues New Warning Regarding Compounded Ketamine

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On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

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THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

Alston & Bird

Health Care Week in Review: DEA Issues Proposed Rules on Controlled Substances Prescribing via Telemedicine

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Wilson Sonsini Goodrich & Rosati

2022-2023 Medical Product and Service Regulatory Initiatives

The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more

King & Spalding

Pharma Investment Trend Report: What We’re Watching in 2023

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2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over forty novel drugs and biologics and...more

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more

Morgan Lewis

Digital Health Trends to Watch in 2022

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In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

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Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

Jones Day

JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes

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Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more

Troutman Pepper Locke

DTC Compounded Medications: A Treatment Option for a System in Need?

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We have all been there: An advertisement on television or a pop-up on Facebook beckons us to try the latest “visit-free,” “delivered to your door” treatment for a medical condition. Originally published in Dermatology Times...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report - Summer 2019

Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 pt 2

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

New Connecticut Law Allows Telemedicine Prescribing of Controlled Substances

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Connecticut has taken another step towards expanding the meaningful use of telemedicine in connection with treatment of mental health and substance use disorders. SB 302, signed by Governor Dannel Malloy and effective July 1,...more

Sheppard Mullin Richter & Hampton LLP

In a Unanimous Vote, the Opioid Crisis Response Act of 2018 Makes it Onto the Legislative Calendar

As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more

Foley & Lardner LLP

Health Care Policy Newsletter - May 2018 pt 3

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Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly Health Care Newsletter” in which we compile the latest health care policy news and legislation....more

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