JD Supra

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

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 ...
FoodNavigator

EC food labeling format: guide to conversion

Converting food and beverage product labels from US to EC format requires an in-depth understanding of European labeling legislation, which is more complex than it often appears to be, regulatory ...
MarketWatch

Cyberonics gets FDA OK for VNS labeling format

SAN FRANCISCO (MarketWatch) -- Cyberonics Inc. said Wednesday it has received approval from the Food and Drug Administration for an armonized/modularized VNS therapy system labeling format. The FDA ...
FierceBiotech

UPDATED: FDA takes step toward standardized medical device labeling

Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United ...
Medscape

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

Purpose: The revised prescription drug labeling developed by the Food and Drug Administration (FDA) is described. Summary: A new FDA final rule, "Requirements on Content and Format of Labeling for ...
PharmTech

FDA Releases Draft Guidance on Labeling of Biosimilars

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug. FDA released a highly ...
FiercePharma

FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of ...