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Federal Food Drug and Cosmetic Act (FFDCA) Jurisdiction

Venable LLP

Implications of Loper Bright for FDA-Regulated Products

Venable LLP on

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

Foley & Lardner LLP

Master of Its Choice of Forum?

Foley & Lardner LLP on

On April 29, 2024, the U.S. Supreme Court agreed to review whether a plaintiff may compel the remand of a case removed on the basis of federal question jurisdiction by voluntarily amending its complaint to leave only state...more

Dechert LLP

Mass Tort Implications of FDA’s First of its Kind State Drug Importation Program

Dechert LLP on

For the first time, FDA approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the U.S., the first program of its kind to allow a state’s importation of pharmaceuticals approved by a...more

Perkins Coie

Weekly Notable Ruling Roundup - October 2023 #2

Perkins Coie on

Our weekly roundup aims to keep our readers up to date on recent notable rulings in the food & consumer packaged goods space. Stephen Dunn, et al. v. Ancient Brands LLC, No. 5:21-cv-00390-LEK-ML (September 15, 2023): The...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

King & Spalding on

On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more

Patterson Belknap Webb & Tyler LLP

Courts Say CBD-Product False Ad Actions Should Mellow During FDA Rulemaking Process

Over the past few months, federal courts throughout the country have stayed litigation challenging the labeling of products infused or made with cannabidiol, better known as CBD. These courts, acknowledging that labeling and...more

Akin Gump Strauss Hauer & Feld LLP

The Federal Circuit Finds Jurisdiction over the ITC’s Decision Not to Institute an Investigation Under Section 337 and Explains...

• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more

Jones Day

Federal Circuit Asserts Jurisdiction to Review ITC’s Non-Institution Decision

Jones Day on

In a long-awaited decision, a split panel of the Federal Circuit confirmed on May 1, 2019, that the Court has jurisdiction to review the ITC’s decision not to institute an investigation. Amarin Pharma, Inc. v. Int’l Trade...more

BCLP

USDA and FDA to Jointly Regulate Cell-Cultured Food Products

BCLP on

The U.S. Department of Health and Human Services’ Food and Drug Administration (“FDA”) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) formally agreed on March 7 to share regulatory...more

Foley Hoag LLP

Product Liability Update - April 2013

Foley Hoag LLP on

In This Issue: - United States Supreme Court Holds Class Certification Improper Absent Showing Plaintiffs’ Damages Can Be Measured on a Classwide Basis through Use of a Common Methodology that Is Consistent with...more

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