Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
Real World Data/Real World Evidence
Exploratory IND Studies
Guidance for Industry, Investigators, and Reviewers – Exploratory IND Studies, Investigational New Drug Applications
Exception from Informed Consent Requirements for Emergency Research
Informed Consent Exception for Emergency Research – Guidance
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
International Council on Harmonisation – Efficacy
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The two countries agreed to negotiate over the next month while collaborating on addressing drug and weapons trafficking.
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