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Appeals Regulatory Requirements Food and Drug Administration (FDA)

Troutman Pepper Locke

Are State ENDS Directories Preempted? Federal Courts Are Split

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Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

McDermott Will & Schulte

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Akin Gump Strauss Hauer & Feld LLP

No Appeal of LDT Decision Means Ball Is Back in FDA’s Court for Policy Clarification

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

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On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

Baker Donelson

Federal Court Vacates LDT Final Rule

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The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more

Mintz - Health Care Viewpoints

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Food and Drug Administration v. Wages and White Lion Investments, LLC

On April 2, 2025, the U.S. Supreme Court decided Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, holding that FDA’s denial of the respondents’ application to market certain flavored...more

MoFo Life Sciences

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

MoFo Life Sciences on

On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

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On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Bradley Arant Boult Cummings LLP

Federal Appeals Court Rules Against Doctor Seeking to Use Mushrooms to Aide Terminal Patients: How We Learned to Question the...

It’s funny how things work out – sometimes you find yourself living in a sort of butterfly effect where the tail seems to wag the dog. In 2023, when we first started writing about the traction psychedelics were gaining as...more

Polsinelli

Federal Circuit Refuses to Rehear Case Involving Orange Book Listing of Device Patents

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Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more

Troutman Pepper Locke

Supreme Court Weighs Vape Venue Dispute

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On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

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ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | June 2018 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Dietary Fiber Labeling - The U.S. Food and Drug Administration has released guidance identifying eight non-digestible carbohydrates that the agency intends...more

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