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Sharan Murugan
Sep 222 min
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...
110
Sharan Murugan
Sep 212 min
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...
140
Sharan Murugan
Sep 152 min
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
410