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June 02, 2015
Will biosimilars share a compendial identity like generic drugs do?
The directorate highlights achievements accomplished during the year of its 50th anniversary.
May 31, 2015
The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.
May 02, 2015
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
April 20, 2015
Serialization experts will share best practices and practical applications at INTERPHEX 2015.
April 01, 2015
USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities-Limits and Elemental Contaminants in Dietary Supplements.
March 25, 2015
The commission adopts 24 new and 72 revised texts for inclusion in the European Pharmacopoeia.
March 02, 2015
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
February 03, 2015
A revision and modernization of the IPEC Significant Change Guide incorporates concepts of risk assessment.
February 02, 2015
This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.