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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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A New Look Representing the Importance of Quality Medication Use

PQA

This is the first major update to PQA’s look since the organization was established in 2006. Our name, our mission and our identity remain unchanged, and we continue to evolve from a position of strength.

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.

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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Pharmaceutical Strategy for Europe. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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Rare Disease Day and a Focus on Quality

PQA

If you have questions or would like to be involved, email us at Communications@PQAalliance.org. __ About PQA and PQA Convenes PQA is a national quality organization dedicated to improving medication safety, adherence and appropriate use.

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RFID: The future of smart labelling?

Pharmaceutical Technology

Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. However, to make it all work – regardless of technology – we need trusted, reliable, global standards that provide a common digital language to communicate that data across the supply chain’” she adds.

Labelling 105
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3 steps for comprehensive patient collaboration

pharmaphorum

He joined Johnson & Johnson in 2001 as Director Corporate Communications. In 2006 he joined the Janssen teams working in Infectious Diseases where he helped to maintain and enhance the company’s relationships with the HIV Patient Community. In that function, he initially worked in the field of oncology.