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applications

Recent FDA Advancements in Rare Diseases – Funding, Partnerships, and Programs

The paucity of therapeutic choices is a reality often acknowledged by the US Food and Drug Administration (FDA) as it reviews applications for new medical …

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Clinical Quality Management System

Clinical Quality Management System (CQMS): A Framework for Operational Excellence and Compliance with Good Clinical Practice (GCP)

What defines “quality” within the framework of clinical research? To answer this question, one has to step back and start with the definition of “quality” …

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clinical trials

Operationalising Decentralised Clinical Trials (DCTs)

The Challenges and Change Management Approaches, Considering Trial Designs and Timelines with Decentralisation Methods at the Forefront While components of fully decentralised clinical trials and …

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drug development

Overview: Pharmacovigilance and Risk Management

Drug development is an expensive, lengthy, and high-risk business taking 1015 years and is associated with a high attrition rate. Approximately only 1 in 10 …

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clinical study

FDA lifts clinical hold on fitusiran

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the …

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