Inside Standards

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December 22nd 2022

Highlights of December 2022 EMA Management Board Meeting

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.

May 26th 2020

FDA Leadership Shifts to Advance COVID-19 Treatments

By Jill Wechsler

June 1st 2015

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

By Randi Hernandez

May 2nd 2015

Ensuring the Quality of Biologicals

May 1st 2015

An Update on the Quality Metrics Initiative

USP Publishes Monoclonal Antibody Guidelines

March 2nd 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 1st 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

BySusan Haigney

January 1st 2015

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

Inside Standards

Latest News

USP Publishes Monoclonal Antibody Guidelines

Tools of the Trade for Preventing Drug Shortages

Standards Organizations Update

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Report - Digital Transformation in Biopharma: The Gap Between Hype and Implementation

Reducing CAR-T Manufacturing Times and Cost: Q&A with Trenchant’s Jon Ellis

How Big Biopharma Investment in CGTs Will Redefine the Industry Pipeline

Industry Leaders Detail Transformational Strategies to Mainstream CAR-T Care

Streamline AAV-based Gene Therapies with High-Performing Off-the-Shelf Plasmids