COMMENT HYMAN WITH Attachment 8-27-13

COMMENT HYMAN WITH Attachment 8-27-13.pdf

Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

COMMENT HYMAN WITH Attachment 8-27-13

OMB: 0910-0765

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Understanding of the Disease

Pert 3:2 Understanding of the Relationship
between the Drug's Effect on Surrogate and the

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Part 4:2 Strength of ClinicalEvidence (Section

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Disease (Section VII.C.10
Epidemiological, Pharmacolog ic, and'Other 1
Evidence on the Surrogate or Disease

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