JD Supra

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 ...
JD Supra

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

FDA’s recent draft guidance, Regulatory Considerations for Prescription Drug Use Related Software, proposes a regulatory framework for software disseminated by a drug sponsor that supplements or ...
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 ...
c-span

Generic Drug Labeling

2014-04-04T21:54:23-04:00https://images.c-span.org/Files/203/20140404221121003_hd.jpgWitnesses testified at a hearing on the Food and Drug Administration’s FDA’s ...
Medscape

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...

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

January 13, 2026 - PRESSADVANTAGE - In the highly regulated field of medical device labeling translation, ensuring that ...