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
The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?
- Author
- An interview with Director of the Division of Cardio-Renal Drug Products Raymond Lipicky M.D.
- C-P Milne
- CH Koch
- Dissemination of information on unapproved/new uses for marketed drugs biologics,devices
- DM Cocchetto
- E Gellhorn
- EM Healy
- Fast track drugs may lose designation if criteria are no longer met-FDA.
- Industry active role in guidance development urged by Wyeth’s Burlington.
- Investigational New Drug Applications
- J Morrison
- J Wechsler
- J Woodcock
- JA DiMasi
- LA Suydam
- LD Fisher
- Loose cannons.
- LR Versteegh
- ML Robinson
- RA Merrill
- Regulations requiring manufacturers to assess the safetyeffectiveness of new drugsbiological products in pediatric patients.
- Remicade off-label RA campaign cleared with balancing statement.
- Standard NDA reviews most affected by downturn in first-cycle NDA approvals Lumpkin asserts.
- USFDA Converting to regulation by guidance.”
- 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