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Regulatory Requirements Prescription Drugs Health Care Providers

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

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On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

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On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

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FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Troutman Pepper Locke

Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast

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Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and Emma Trivax delve...more

McDermott Will & Emery

Trending in Telehealth: April 2025

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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

Bradley Arant Boult Cummings LLP

DEA Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations

On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

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The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

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The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Akerman LLP - Health Law Rx

Harmonizing Federal and Florida Laws on Prescribing Controlled Substances Through Telehealth

Practitioners who want to prescribe controlled substances via telehealth to patients in Florida must meet the requirements of both federal and state law. The federal Drug Enforcement Administration (DEA) and the Florida...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

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Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...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

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Wiley Rein LLP

[Podcast] Pharmacy Benefit Segmentation: Emerging Models for Health Plans

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In this episode of The Wiley Contracting Chronicles, hosts Jordan Ross and Brooke DeLoatch discuss the growing trend of pharmacy benefit segmentation among health plans. They outline three emerging models identified at Wiley:...more

McDermott Will & Emery

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

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California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...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

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

McDermott Will & Emery

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

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Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

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On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more

McDermott Will & Emery

FDA Relaxes on Use of Scientific Info in Off-Label Communications

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On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

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On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Roetzel & Andress

Prescribing GLP-1 Medications: Be Aware of Legal Limitations

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On this episode of HealthLawHotSpot, Roetzel attorneys Ericka Adler and Christina Kuta discuss the potential pitfalls and best practices in dispensing GLP-1 medications.Christina shares her insights on the surge in demand,...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

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On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Jones Day

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

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The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

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