FDA Law Blog: Biosimilars

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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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Documentation Adverse Reactions Communication Drug Development 105

European Pharmaceutical Review

JUNE 24, 2022

But what are the key potential changes and how could they impact drug developers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drug development in the orphan and unmet medical need areas. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2006.

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Pharmaceutical Technology

JANUARY 26, 2023

The company’s name is perhaps most commonly associated with developing clinical-grade pluripotent stem cells – an offshoot from the scientific milestone of Dolly the Sheep, the world’s first mammal to be successfully cloned from the cell of an adult. We are all aligned and in frequent communication with each other.

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Communication Diabetes Drug Development 52

Putting Patients First Blog

APRIL 30, 2024

This method not only prioritizes the participant’s comprehension but also aligns with best practices in health communication that suggests a focused approach can significantly enhance understanding and retention of important information. The importance of using plain language in health communications is well-documented in literature.

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Documentation Communication Mayo Clinic Drug Development 52