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Product Labels Pharmaceutical Industry

Hissey, Mulderig & Friend, PLLC

Depo-Provera Birth Control Shots and the Risk of Meningioma Brain Tumors

Depo-Provera, a birth control injection containing the hormone medroxyprogesterone acetate, has been widely used for decades as a convenient contraceptive option. For many women, the Depo shot offered an alternative to daily...more

Alston & Bird

Class Action & MDL Roundup | 2025 Q1 – Our Terms Define Class

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Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the first quarter of 2025. In this edition, two UK actions fail to clear a low bar, a movie isn’t a video, and spam isn’t...more

Morris James LLP

Meningioma and Birth Control Lawsuits: The Case Against Depo-Provera

Morris James LLP on

Women across the country are taking legal action against Pfizer, the manufacturer of Depo-Provera, alleging that the company failed to warn about the risks of developing meningiomas — generally non-cancerous but potentially...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

DLA Piper on

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Fishman Haygood LLP

U.S. Third Circuit Rejects Claims of Preemption and Allows Fosamax Cases to Proceed

Fishman Haygood LLP on

In 2022, over 500 plaintiffs filed a case alleging that Merck Sharp & Dohme Corp., a drug manufacturing company, failed to provide adequate warnings that one of their drugs increased the risk of atypical femoral fractures....more

Quarles & Brady LLP

New York Passes Much-Anticipated Law Authorizing Pharmacy Shared Services Arrangements

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On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more

Kilpatrick

E.D.N.Y. deals blow to plaintiffs’ claims – including mislabeling, false advertising and RICO claims – in multidistrict litigation...

Kilpatrick on

Takeaway: When it comes to mislabeling and related claims, and especially when human safety is not implicated, express preemption under the federal Food, Drug and Cosmetic Act (FDCA) remains a powerful tool in the hands of...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Axinn, Veltrop & Harkrider LLP

Federal Circuit Provides Useful Guidance on Skinny Label Claims

When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

Polsinelli on

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Axinn, Veltrop & Harkrider LLP

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

Alston & Bird

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

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Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Alston & Bird

Class Action & MDL Roundup 2023 Q4 - Not All Cases Survive and Advance

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Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

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Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

K&L Gates LLP

An Overview of the US Food and Drug Administration's Legislative Goals (Part I)

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In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more

Arnall Golden Gregory LLP

FDA Issues New Draft Guidance on Regulatory Considerations for Prescription Drug Use-Related Software

New technologies continue to emerge that improve care for patients taking prescription medications. On September 18, 2023, five years after the Food and Drug Administration sought initial public comment, the agency issued its...more

Axinn, Veltrop & Harkrider LLP

GSK v. Teva's Continued Ripple Effects

As we continue to assess the ripple effects from the Supreme Court's denial of certiorari in GlaxoSmithKline v Teva Pharms USA (GSK v Teva), a recent decision by Judge Andrews in the U.S. District Court for the District of...more

Venable LLP

New FDA Guidance Removes Interchangeability Statement from Product Labels

Venable LLP on

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. ...more

Goodwin

FDA Releases Draft Labeling Guidance for Biosimilar Products

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Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for...more

Wilson Sonsini Goodrich & Rosati

FDA Cracks Down on Unapproved Eye Products

On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more

Sheppard Mullin Richter & Hampton LLP

Context is Key: FDA Sends a Strong Message About Efficacy Claims

On August 4, 2023, the Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a Warning Letter to AstraZeneca which stated that the company made misleading claims in a promotional sales aid...more

Quarles & Brady LLP

Brace Yourself: DEA’s Final Rule on Quotas Squeezes Inventory Levels and Signals Further Supply Restrictions

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On August 31, 2023, DEA published a final rule (“Final Rule”) regarding its management of controlled substance and List 1 Chemical (“L1 Chemical”) quotas for DEA-registered manufacturers. The Final Rule largely tracks DEA’s...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2023

Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

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The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

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