Back to Results
First PageMeta Content
Pharmacology / Pharmaceutical industry / Drug safety / Clinical Data Management / Electronic Common Technical Document / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Clinical trial / Common Technical Document / Good Clinical Practice / Clinical research / Research / Pharmaceutical sciences


Guidance for Industry E3 Structure and Content of
Add to Reading List

Open Document

File Size: 141,13 KB

Share Result on Facebook

Company

Efficacy Implementation Working Group / /

Country

Japan / United States / /

/

Event

FDA Phase / /

Facility

Rockville Pike / /

/

IndustryTerm

pharmaceutical industry / guidance Web page / /

MedicalCondition

cancer / chronic kidney disease / /

MedicalTreatment

gene therapy / chemotherapy / dialysis / /

Organization

U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Center for Biologics / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /

Person

Silver Spring / /

/

Position

investigator / original investigator / /

Product

M-16 / E3 / A7 / /

Technology

gene therapy / pharmacokinetics / diagnostic tests / chemotherapy / pharmacodynamics / stem cells / dialysis / /

URL

http /

SocialTag