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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Infant, Newborn ✖Remove constraint Subjects: Infant, Newborn Copyright Public domain ✖Remove constraint Copyright: Public domain

1. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
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.

2. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, November 28, 2017
Subject(s):
Equipment Safety -- standards
Product Labeling -- standards
Radiation Dosage
Radiation Exposure -- adverse effects
Radiation Exposure -- standards
Radiography -- adverse effects
Radiography -- instrumentation
Adolescent
Child
Child, Preschool
Contraindications
Fluoroscopy -- adverse effects
Fluoroscopy -- instrumentation
Infant
Infant, Newborn
Radiation, Ionizing
Tomography Scanners, X-Ray Computed -- standards
Tomography, X-Ray Computed -- adverse effects
Young Adult
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Newborn health: federal action needed to address neonatal abstinence syndrome : report to Congressional addressees

Publication:
Washington, D.C. : U.S. Government Accountability Office, October 2017
Subject(s):
Neonatal Abstinence Syndrome -- economics
Neonatal Abstinence Syndrome -- therapy
Infant, Newborn
Insurance Coverage -- economics
Medicaid -- economics
Mothers
Neonatal Abstinence Syndrome -- drug therapy
Opioid-Related Disorders
Patient Education as Topic
Pregnancy
Prenatal Care
Social Stigma
Substance-Related Disorders -- therapy
Humans
United States
United States. Department of Health and Human Services.

4. Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk

Publication:
College Park, MD : Center for Food Safety and Applied Nutrition, May 2019
Subject(s):
Food Contamination -- prevention & control
Food Safety
Infant Formula -- standards
Milk, Human -- chemistry
Carcinogenicity Tests
Infant
Infant, Newborn
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.