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Sharan Murugan
Jul 32 min read
ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...
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Sharan Murugan
Sep 8, 20221 min read
USFDA Guidance: Submitting Documents Using Real-World Data & RW Evidence for Drug & Biologics
Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...
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