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Supreme Court of the United States › Food and Drug Administration (FDA)

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
McGlinchey Stafford

Let SCOTUS Decide: Can an Amended Complaint ‘Remove’ Removal Jurisdiction?

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On October 7, 2024, the Supreme Court heard arguments to answer two longstanding questions on removal jurisdiction: (1) Whether amending a complaint to eliminate the only federal questions destroys federal subject-matter...more

Haug Partners LLP

United Therapeutics Corporation Certiorari Petition Denied, Creates a Lose-Lose Situation

Haug Partners LLP on

On Monday, October 7, 2024, the U.S. Supreme Court (“SCOTUS”) denied United Therapeutics Corporation (“UTC”) petition for certiorari clearing the way for Liquidia Corporation (“Liquidia”) to launch its Yutrpia® drug product....more

Foley Hoag LLP

Supreme Court Declines Certiorari Review in Cellect

Foley Hoag LLP on

On October 7, 2024, the Supreme Court declined to hear Cellect LLC v. Vidal, No. 23-1231. The case has been followed closely by patent professionals ever since the Federal Circuit upended the judicially-created doctrine of...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference"

McDonnell Boehnen Hulbert & Berghoff LLP on

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

Troutman Pepper

State AGs File Amicus Curae Brief in US Supreme Court Case Involving Flavored E-Cigarettes

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Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for...more

Knobbe Martens

Federal Circuit Review | August 2024

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Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more

King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

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On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

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For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Troutman Pepper

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

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The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

BCLP

Selected Recent Developments for Public Companies

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Public companies should take note of several recent developments, including: ..Reversal of the Pegasystems trade secrets lawsuit that nevertheless preserves guidance to take care when describing litigation as “without...more

Fenwick & West LLP

Disclosure Trend: Risk Factors Post-Chevron

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Life sciences companies are adding risk factor language in response to the U.S. Supreme Court overturning the Chevron Doctrine. As you may recall, the U.S. Supreme Court recently overturned the Chevron Doctrine....more

Parker Poe Adams & Bernstein LLP

Two Recent Supreme Court Decisions Could Dramatically Impact Health Care Regulatory Challenges at the Federal and State Levels

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For nearly 40 years, federal courts have been required to defer to an agency’s interpretation of an ambiguous statute, even if the court did not agree with that interpretation. This deference, commonly referred to as Chevron...more

Foley & Lardner LLP

FDA: The Effects of Loper on the Regulatory Agenda

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The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more

Akin Gump Strauss Hauer & Feld LLP

The Top 10 Takeaways for Businesses from the Supreme Court’s Three Big Administrative Law Decisions in 2024

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Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more

Maron Marvel

Will EPA’s Recent Ban on Methylene Chloride Uses Result in Exponential Litigation Similar to Asbestos?

Maron Marvel on

Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Spilman Thomas & Battle, PLLC on

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Foley Hoag LLP

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Foley Hoag LLP on

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

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In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Jackson Lewis P.C.

What U.S. Supreme Court Decision on Standing Tells Us About Challenges to Corporate DEI Initiatives

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The U.S. Supreme Court held that a group of doctors, nurses, and medical associations did not have the right under the U.S. Constitution, a doctrine known as “standing,” to challenge Food and Drug Administration (FDA)...more

Hogan Lovells

Chevron’s demise brings promises & perils for life sciences companies

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The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more

ArentFox Schiff

Post-Chevron Health Care Regulations: The Dawn of a New Day

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On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

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Recently, Venable's Government Division offered its general thoughts on the fallout from the Supreme Court's reversal of the long-standing Chevron deference principle. Here, the FDA Practice Group offers some of its own...more

Axinn, Veltrop & Harkrider LLP

The Floodgates Have Opened: Supreme Court Scuttles Chevron, Brings New Uncertainty to Regulated Industries

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For forty years, Chevron has put a thumb on the scales in favor of the executive agencies whenever their decisions were challenged in court. Now, the Supreme Court has overturned that longstanding precedent, issuing its...more

Schwabe, Williamson & Wyatt PC

Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry

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“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more

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