Alan Klein

Alan Klein

Duane Morris LLP

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FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more

11/12/2013

Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the...more

7/5/2013 - Design Defects Drugs FDA FDCA Generic Drugs Mutual Pharmaceuticals v Bartlett Pharmaceutical Prescription Drugs SCOTUS

Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products

On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. ...more

3/28/2013 - Biologics Biosimilars FDA Notice Requirements Pharmaceutical Pharmacies Prescription Drugs

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