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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.

Highlights of December 2022 EMA Management Board Meeting

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

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. 

FDA Leadership Shifts to Advance COVID-19 Treatments

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

Will biosimilars share a compendial identity like generic drugs do?

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

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.

Ensuring the Quality of Biologicals

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

An Update on the Quality Metrics Initiative

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

USP Publishes Monoclonal Antibody Guidelines

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

Tools of the Trade for Preventing Drug Shortages

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

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

Inside Standards