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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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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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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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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.

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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.

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How real human experiences can power a healthier future

pharmaphorum

She has held various positions, since joining Janssen in 2006 – prior to her current role, Maria was Global VP & Chief Information Officer of Actelion, and a member of the Actelion leadership team based in Basel, Switzerland. Long life care: ageing populations are growing in size and increasing the pressure on healthcare systems.

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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.