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Healthcare › Labeling

Searcy Denney Scarola Barnhart & Shipley

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

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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

Health Care Compliance Association (HCCA)

OCR: Rule Halts Disclosures Under ‘Presumption of Lawfulness,’ Shares Model Attestation Form

Health Care Compliance Association (HCCA) on

Attestations are at the heart of permissible disclosures under the HHS Office for Civil Rights’ (OCR) new reproductive health privacy rule—and OCR wants covered entities (CEs) and business associates (BA) to use them now. The...more

Manatt, Phelps & Phillips, LLP

FTC Regulation Tracker – March 2024

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The Final Rules keep rolling in, but with a twist. Each of the two Final Rules released in March were accompanied by Supplemental Notices of Proposed Rulemaking. In both cases, the Supplemental Rulemakings, if adopted, would...more

Polsinelli

FDA 2023-24: A Look Back & A Peek Forward

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Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more

Foley Hoag LLP

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

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On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

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On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more

Wilson Sonsini Goodrich & Rosati

FDA Cracks Down on Unapproved Eye Products

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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

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

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US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

McDermott Will & Emery

TTB Issues Four-Part Series on Health-Related Alcohol Marketing Claims

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As consumers continue to trend toward more health-conscious options, including in their choice of alcoholic beverages, the Alcohol and Tobacco Tax and Trade Bureau (TTB) has responded with guidance on health-related marketing...more

Searcy Denney Scarola Barnhart & Shipley

FDA: Blood Volume Expanders Present Severe Risks for Patients

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On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued new warnings regarding hydroxyethyl starch (HES) blood volume expanders. Specifically, the FDA is now requiring manufacturers to update the safety labels for...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

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The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

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The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

McDermott Will & Emery

Detailed Summary of Federal Requirements for Production of Hand Sanitizing Products

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To meet the growing need for hand sanitizing products, various federal agencies including the Alcohol Tobacco Tax and Trade Bureau (TTB), Federal Drug Administration (FDA), Health and Human Services (HHS) and Congress have...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

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The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory...more

Butler Snow LLP

Pro Te: Solutio – Vol. 12, No. 2

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Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice. The...more

Troutman Pepper

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

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The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Hogan Lovells

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

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Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

Stinson LLP

FDA: The Powdered Gloves Come Off

Stinson LLP on

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

Bennett Jones LLP

Health Canada Proposes Changes to the List of Recognized Standards for Medical Devices

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Changes affecting the approval of medical devices are coming. On May 6, 2015, Health Canada released a draft List of Recognized Standards for medical devices for stakeholder consultation. The consultation period is open...more

Robins Kaplan LLP

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA

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The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

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