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Food and Drug Administration (FDA) Corporate Counsel

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

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In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

K&L Gates LLP

FDA Weighs in on Microplastics and Nanoplastics in Food

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In a development that is expected to complicate many litigation challenges alleging that the presence of low levels of microplastics in food is inherently unsafe, officials from the US Food and Drug Administration (FDA or...more

Bergeson & Campbell, P.C.

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

Vicente LLP

4 Major Implications of Cannabis Moving to Schedule III

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After 50 years of being on the most restrictive schedule alongside drugs like heroin and PCP, the DEA will move to reschedule marijuana in Schedule III, where the plant’s medical benefits will finally be recognized by the...more

Husch Blackwell LLP

Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges

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In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private...more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

TransPerfect Legal on

In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

Gardner Law

[Hybrid Event] Navigating the M&A Waters of FDA-Regulated Companies - May 18th, Spring Park, MN

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Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more

McDermott Will & Emery

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

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McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Holland & Knight LLP

FTC Seeks First-Ever Health Breach Notification Rule Enforcement: Pixel Users Beware

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For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more

Hogan Lovells

(Patient) safety first: take steps now to promote good governance by your board

Hogan Lovells on

Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board for breach of fiduciary duties regarding safety oversight. While the Boeing...more

Foley & Lardner LLP

Federal Agencies Issue Firm Reminder that No-Cost Coverage Requirements for Employee Contraceptives Remain Post-Roe

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On July 28, 2022, in light of the United States Supreme Court’s recent decision overturning Roe v. Wade, the United States Department of Labor (DOL), in conjunction with the Departments of Health and Human Services (“HHS”)...more

Wilson Sonsini Goodrich & Rosati

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

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Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Morrison & Foerster LLP - Class Dismissed

Till The Cows Come Home: Tenth Circuit’s Affirmation Of Federal Preemption Is A Win For Defendants In Food Labeling Cases

The Tenth Circuit recently held that the Federal Meat Inspection Act (FMIA) gets the final word on what “Product of the U.S.A.” means for labels of beef products. Thornton v. Tyson Foods, Inc., No. 20-2124, 2022 WL 727628...more

Arnall Golden Gregory LLP

Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more

Fitch, Even, Tabin & Flannery LLP

Recent Federal Circuit Decisions Find Many Internet Documents Are “Printed Publications”

The Federal Circuit has recently provided substantial guidance on whether printed publications include documents publicly available via the internet. This article reviews four such cases that illustrate the expansive view...more

Epstein Becker & Green

New Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing

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Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home...more

Tarter Krinsky & Drogin LLP

U.S. Travel Bans Lifted Effective November 8: What Foreign Visitors Need to Know

In a Twitter announcement on October 15, the White House announced that the U.S. will introduce a new travel policy that will begin on November 8, permitting foreign nationals access to the United States provided they have...more

Kelley Drye & Warren LLP

FTC/FDA Cease and Desist Letters to Companies Touting Diabetes Cures: Is the FTC Testing the Limits of Its Civil Penalty...

As they often have done in the past, the FTC and the FDA issued joint cease and desist letters last week to 10 companies suspected of making unproven health claims – in this instance, claims that dietary supplements treat or...more

Husch Blackwell LLP

50-state Update On Pending Legislation Pertaining To Employer-Mandated Vaccinations - Updated July 2021

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Under federal guidance, private employers can generally require employees to get vaccinated COVID-19, and private businesses can permit entry and service only to vaccinated individuals, as long as they comply with federal...more

Troutman Pepper

SEC Cases Offer Insight into Its Approach to Alleged COVID-19 Securities Fraud

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A remote status conference was held June 28 for United States v. Mark Schena, currently pending in the U.S. District Court for the Northern District of California. In the recently unsealed superseding indictment, the SEC...more

McDermott Will & Emery

[Ongoing Program] Life Sciences Bootcamp Series - FDA and IP - May 25th, 11:00 am ET

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Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Emery

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Consumer Protection and FDA - May 18th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

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