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New FDA guidance document for trails. I have

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nidan7500   Sunday, 02/03/19 03:44:27 PM
Re: nidan7500 post# 180295
Post # of 244062 
New FDA guidance document for trails. I have posted here what I call..."A2-73 ERP Objective evidence for Early Approval Clause." Also, please review section IV.

Quote:
For special considerations related to use of biomarkers as surrogate endpoints, see section VI.,
Efficacy Endpoints.

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is thought to be able to predict clinical benefit but is not by itself a measure of clinical benefit. Effects on some surrogate endpoints (e.g., blood pressure, low-density lipoprotein cholesterol) are well established predictors of clinical benefit for certain indications and are regularly used as the basis for traditional approval of drugs. Less well established surrogate endpoints, but which are considered reasonably likely to predict clinical benefit, may be used as a basis for accelerated approval for treatment of serious or life-threatening diseases



https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM629579.pdf?rel=0


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