News & Analysis as of

Jurisdiction Food and Drug Administration (FDA)

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

Foley & Lardner LLP

Master of Its Choice of Forum?

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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

Array

eDiscovery and ANDA Litigation: Unique Timelines, Processes, and Workflows

Array on

ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more

Dechert LLP

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

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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

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Latham & Watkins LLP

FDA to Address Proposed Rule to Subject Laboratory Developed Tests to Agency Oversight in Public Webinar

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FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach. On October 31,...more

Foley & Lardner LLP

CPSC Signals its Regulatory Interest in PFAS

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On September 20, 2023, the Consumer Product Safety Commission (CPSC) issued a Federal Register Notice and Request for Information asking for public comment about the use and presence of per- and polyfluoroalkyl substances...more

King & Spalding

FDA's Latest Salvo in the LDT Wars

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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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - March 2021

The March 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses fair use cases for photographs and three recent developments in the cannabis space. We also highlight recent accolades earned by Sterne Kessler's...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

Womble Bond Dickinson

Proposed California CBD Class Action Stayed: Primary Jurisdiction Doctrine Again Halts a CBD Suit

Womble Bond Dickinson on

As the CBD industry continues to wait for the U.S. Food and Drug Administration (FDA) to begin the rulemaking process for the regulation of cannabis-derived products — which will hopefully provide some clarity regarding how...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

Proskauer - Advertising Law

Snack Bar Class Action Powers On After USDA Action and FDA Inaction

Unlike a fine wine, a snack bar does not get better with age. Neither, apparently, does litigation. Last month, Judge William H. Pauley III in the Southern District of New York lifted a years-long stay in a lawsuit against...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

Hogan Lovells

USDA and FDA Settle Jurisdiction over Products Derived from Livestock and Poultry Cell Lines

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The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of...more

Steptoe & Johnson PLLC

WV Supreme Court Kicks Failure to Warn Case Under Michigan Law

The West Virginia Supreme Court of Appeals recently upheld the Mass Litigation Panel’s grant of summary judgment against a class of Plaintiffs alleging birth defects resulting from the use of prescription medicine in...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Morrison & Foerster LLP - Class Dismissed

Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action

The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On January 26, 2015, the Ninth Circuit granted General Mills’ motion to...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Morris James LLP

Transfer Motion Is Denied

Morris James LLP on

Instead of applying admittedly neutral Jumara factor arguments, Defendants urge the court to transfer instead based on the singular fact that the Maryland court had rendered a decision on a related patent and, thus, any forum...more

Mintz - Consumer Product Safety Viewpoints

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

Robins Kaplan LLP

Acorda Therapeutics, Inc. v. Mylan Pharms. Inc.

Robins Kaplan LLP on

Case Name: Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., Nos. 14-935-LPS, 2015 U.S. Dist. LEXIS 4056 (D. Del. Jan. 14, 2015) (Stark, C.J.). Drug Product and Patent(s)-in-Suit: Ampyra® (dalfampridine); U.S. Pats. Nos....more

McDermott Will & Emery

No Declaratory Jurisdiction Without Biosimilarity Application on File with FDA - Sandoz Inc. v. Amgen Inc.

McDermott Will & Emery on

Avoiding an interpretation of the Biologics Price Competition and Innovation Act (BPCIA), the U.S. Court of Appeals for the Federal Circuit invoked traditional case or controversy principles to affirm the dismissal of a...more

K&L Gates LLP

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to...

K&L Gates LLP on

The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory...more

Knobbe Martens

Federal Circuit Affirms Dismissal in Sandoz v. Amgen under Traditional Jurisdictional Grounds and Declines First Opportunity to...

Knobbe Martens on

In the first Federal Circuit case involving the Biologics Price Competition and Innovation Act (“BPCIA” or “Biosimilars Act”), the Court of Appeals for the Federal Circuit affirmed Judge Maxine E. Chesney’s (N.D. Cal.)...more

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