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McDermott Will & Emery

This Week in 340B: August 20 – 26, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Searcy Denney Scarola Barnhart & Shipley

Exploring Treatment Options for Exactech Shoulder Issues: Surgery vs. Non-Surgical Approaches

The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more

A&O Shearman

Health Care Company Secures Antitrust Victory With Jury Verdict In Its Favor

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On August 1, 2024, a unanimous jury in the United States District Court for the Northern District of California found plaintiff, a veterinary drug manufacturer, failed to allege a relevant antitrust market under Sherman Act,...more

McDermott Will & Emery

This Week in 340B: August 2 - 7, 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Hogan Lovells

Negotiating cell, tissue, and gene therapy agreements with health care organizations

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Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...more

McDermott Will & Emery

This Week in 340B: July 2 – 8, 2024

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Searcy Denney Scarola Barnhart & Shipley

The Role of the FDA in the Exactech Recall: A Critical Analysis

Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more

Searcy Denney Scarola Barnhart & Shipley

Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Gardner Law

Navigating HIPAA and State Privacy Laws for Drug and Device Manufacturers

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The Health Insurance Portability and Accountability Act of 1996 as amended and implemented through regulations at 45 C.F.R. §§ 160 and 164 (“HIPAA”) regulates the privacy and security of health information. For drug and...more

Alston & Bird

Health Care Week in Review: Senate Finance Committee Releases Plan to Address Workforce Shortages, Court Sides with Manufacturers...

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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

Foley & Lardner LLP

New Favorable OIG Advisory Opinion Allows Patient Assistant Programs Funded by Drug Manufacturers

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The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more

Womble Bond Dickinson

[Event] Mastering Innovation Through Intellectual Property: Strategies for Every Sector - May 7th, Denver, CO

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Join IP Partners Preston Heard, Barry Herman, and Christy Dupriest in Denver on Tuesday, May 7th at 4:30pm (MDT) for drinks and discussion on effective IP strategies. In a social and casual setting, learn how to safeguard...more

Searcy Denney Scarola Barnhart & Shipley

Alternatives to the Exactech: Exploring Other Surgical Tools and Techniques

Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

Mintz - Health Care Viewpoints

Connecticut Law Imposes New Requirements on Pharmaceutical Manufacturers, Defined to Include Device and Cosmetic Manufacturers,...

Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...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

Dechert LLP

FDA Issues Revised Draft Guidance on “Off-Label” Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain

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The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance supersedes FDA’s 2014 Draft Guidance on...more

Harris Beach PLLC

Cochlear Implant Manufacturer Proposes to Provide Free Compatible Hearing Aids

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This opinion addresses a proposed arrangement (“Proposed Arrangement”) by the manufacturer of cochlear implants (“Requestor”), where the Requestor would provide certain patients who receive one of their implants with a free...more

Troutman Pepper

FDA Issues New Draft Guidance for Unapproved Use Communications

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On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Knobbe Martens

Major Med Device Product Developer GE HealthCare Collaborating with Healthcare Providers

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For good reasons, including product safety, quality assurance, development of delivery procedures and instructions, it has been a common practice for medical device companies and innovators to consult with physicians during...more

Hogan Lovells

New Connecticut rules for drug makers employing sales reps take effect Oct. 1

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The state of Connecticut recently enacted HB6669, which requires registration of pharmaceutical manufacturers employing sales representatives who interact with health care professionals (HCPs) in Connecticut. The portions of...more

Wilson Sonsini Goodrich & Rosati

FDA Cracks Down on Unapproved Eye Products

On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2023 #1

News Briefs - More States Introducing 'Conscience' Healthcare Bills - A new Montana law will provide sweeping legal protections to healthcare practitioners who refuse to prescribe marijuana or participate in procedures and...more

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