EurekAlert!

ACR responds to FDA draft guidance on biosimilars labeling

ATLANTA - "The American College of Rheumatology (ACR) commends the Food and Drug Administration (FDA) for issuing new draft guidance recommending that biosimilar labeling clearly differentiates ...
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 ...
JD Supra

A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars

The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised ...
The National Law Review

A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars

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 ...
Healio

A ‘more useful’ drug label: FDA seeks to add immunogenicity section to biologic labels

Please provide your email address to receive an email when new articles are posted on . Although immune-based therapies have penetrated many medical specialties, including rheumatology, some experts ...