3 research outputs found
Needs and new Policies For Medicines for Children: The FDA, United States Incentives, and International Doings
- Author
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
Questions and Answers on Labeling of Drugs for Children
- Author
- A Hiller
- A Rane
- Additional protections for children involved as subjects in research.
- AF Holmer
- AM Glasgow
- American Academy of Pediatrics Committee on Bioethics 1993-1994.
- American Academy of Pediatrics Committee on Drugs, 1994–1995.
- American Academy of Pediatrics Committee on Drugs.
- B Bailey
- CJ Coté
- DL Mevorach
- Drug Information for the Health Care Professional.
- EB Trait
- FDA Proposed Rule of Pediatric Labeling.
- FDA Proposed Rule on Pediatric Labeling.
- FH Lovejoy
- FJ Suchy
- G Koren
- G Martin
- GL Kearns
- H Taussig
- HC Shirkey
- HC Shirkey
- IS Gauntlett
- J Gershanik
- JD Lloyd-Still
- JJ McCloskey
- JM Sutherland
- JR Nielson
- JT Gilman
- JT Gilman
- JT Wilson
- JT Wilson
- JT Wilson
- JT Wilson
- KE Bove
- KT Olkola
- L Hendeles
- L Hendeles
- LB Sheiner
- LE Bums
- LM Pina
- M Weinberger
- MG MacDonald
- National Institutes of Health RFA# HD-98-002 Network of Pediatric Pharmacology Research Units.
- National Institutes of Health RFA# HD-93-06 Network of Pediatric Pharmacology Research Units.
- OTC Switch Drugs.
- Over-The-Counter human drugs
- Prescription drug advertising
- Protection of human subjects-proposed regulations on research involving children.
- R Agarwal
- RD Brown
- RE Kauffman
- RE Kauffman
- RJ Roberts
- SJ Yaffe
- Specific requirements on contentformat of labeling for human prescription drugs
- Unusual syndromes with fatalities among premature infants: Association with a new intravenous vitamin-E product.
- V Lorch
- VJ Rounds
- WA Silverman
- WF Balistreri
- WI Brown
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study
Pediatric Drug Development: The International Conference on Harmonization Focus on Clinical Investigations in Children
- Author
- AL Pereira
- AWM Scott
- B Geller
- BA Larsson
- CF Stewart
- Clinical Investigation of Medicinal Products in the Pediatric Population: Draft ICH Consensus Guideline.
- Committee on Drugs American Academy of Pediatrics.
- Committee on Drugs American Academy of Pediatrics.
- Committee on Drugs American Academy of Pediatrics.
- Convention on the Rights of the Child.
- D Berdcl
- DB Allen
- Declaration of Helsinki revised.
- DR Butler
- E Samara
- GL Kearns
- GP Aylward
- Guidelines for the clinical evaluation of drugs in pediatric patients.
- GW Ladd
- H Shirkey
- HG Schaefer
- IF Litt
- International Conference on Harmonization Good Clinical Practices
- JD Marshall
- JG Simeon
- JL Blumer
- JP Kemp
- JS Leeder
- JS Leeder
- JT Gilman
- JW Finkelstein
- KPJ Tercyak
- L Zarbatany
- LA Weithorn
- M Vanelli
- MC Manley
- MC Nahata
- MC Nahata
- MD Reed
- MD Reed
- MR Simar
- NC Santanello
- Note for guidance on clinical investigation of medicinal products in children.
- PD Walson
- PL Morselli
- PM Wax
- PR Stein
- R Bishai
- RE Kauffman
- Regulations requiring manufacturers to assess the safetyeffectiveness of new drugsbiological products in pediatric patients
- Report of the Working Party on Registration of Drugs in Children.
- ReportRecommendations: Research Involving Children.
- SA Amiel
- SM Lesko
- Specific requirements on contentformat of labeling for human prescription drugs
- SS Gidding
- Statement by the Steering Committee.
- T McRorie
- Therapeutic Products Directorate guidelines: Inclusion of pediatric subjects in clinical trials.
- Publication venue
- 'SAGE Publications'
- Publication date
- Field of study