Inside Standards

Highlights of December 2022 EMA Management Board Meeting

December 22, 2022

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

FDA Leadership Shifts to Advance COVID-19 Treatments

May 26, 2020

The White House looks to bring in credible experts for its Operation Warp Speed initiative to advance therapies and vaccines to combat the coronavirus pandemic.

What’s In a Name? For Biosimilars, A Lot

June 01, 2015

Will biosimilars share a compendial identity like generic drugs do?

Ensuring the Quality of Biologicals

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.

An Update on the Quality Metrics Initiative

May 01, 2015

Industry and regulatory agencies continue to make progress in establishing quality metrics for the pharmaceutical industry.

USP Publishes Monoclonal Antibody Guidelines

March 02, 2015

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

Tools of the Trade for Preventing Drug Shortages

March 01, 2015

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Standards Organizations Update

January 01, 2015

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.