E11(R1) addendum: clinical investigation of medicinal products in the pediatric population
- Series Title(s):
- Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
- Clinical Trials as Topic -- ethics Drug Compounding -- standards Pediatrics Pharmaceutical Preparations Child Excipients Infant Infant, Newborn International Cooperation Models, Theoretical Pharmaceutical Preparations -- administration & dosage Taste Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (11 pages)).
- Revision 1
- NLM Unique ID:
- 101734090 (See catalog record)