Drug Labelling Regulations

Shire v. Blackburn: Drawing the Line Between FDA Drug Labeling Regulations and State Law on Product Liability

On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state ...

The National Law Review

FDA Reminds Stakeholders of Animal Drug ‘Approved by FDA’ Labeling Requirements

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

JD Supra

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Last week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug ...

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Shire v. Blackburn: Drawing the Line Between FDA Drug Labeling Regulations and State Law on Product Liability

FDA Reminds Stakeholders of Animal Drug ‘Approved by FDA’ Labeling Requirements

FDA proposes mandatory patient labeling for Rx drugs - Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling

Generic Drug Labeling

FDA sends front-of-package nutrition labeling proposal to OMB

Language Scientific Outlines What “Quality” Means in Medical Device Labeling Translation