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Enforcement › Food and Drug Administration (FDA) › Health Care Providers

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

Sheppard Mullin Richter & Hampton LLP on

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Foley & Lardner LLP

Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers

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The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more

Foley & Lardner LLP

GLP-1 Drugs: FDA “Re-Confirms” Decision Removing Tirzepatide from the Drug Shortage List

Foley & Lardner LLP on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more

Harris Beach Murtha PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

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The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

Foley & Lardner LLP

FDA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages

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In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more

Seyfarth Shaw LLP

FDA Eases Enforcement to Help Make More Ventilators Available

Seyfarth Shaw LLP on

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

McDermott Will & Emery

Special Report - 2019 Digital Health Year in Review - January 2020

McDermott Will & Emery on

Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

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