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Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com
FDA Halts Clinical Trials That Send US Patient Cells to Foreign Labs

June 20th 2025

Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.

In Modern Laboratory Senior Female Scientist Has Discussion with Young Male Laboratory Assistant. He Shows Her Data Charts on a Clipboard, She Analyzes it and Enters It into Her Computer. | Image Credit: © Gorodenkoff - stock.adobe.com
Taking Full Advantage of Service Providers

April 1st 2024

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Lilly to Acquire POINT Biopharma

October 5th 2023

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Evecxia Therapeutics and Quotient Sciences Complete Phase I Clinical Milestone

September 25th 2023

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Clinical Trials and their Impact on the Pharma Industry

September 1st 2023

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World Courier Adds New Distribution Center in Australia

Randi Hernandez
February 13th 2015

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

Mikal Sherman;Christopher R. Cruz;Christel Fenge, PhD;Jessica Martin;Rüdiger Heidemann, PhD;Paul Wu, PhD
October 1st 2014

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

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ISPE Releases Report on Survey of Patient Experiences with Clinical Trial Materials

BioPharm International Editors
November 6th 2013

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

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Considerations When Outsourcing the Production of Clinical Material

Josée Ethier;Chantal Déziel
June 1st 2008

It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.

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Outsourcing: Nonclinical Development Becoming a Big Business

Jim Miller
July 1st 2006

The lack of biomanufacturer acquisitions seems surprising.

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