# Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-study-plans-content-of-and-process-for-submitting-initial-pediatric-study-plans-and-amended-initial-pediatric-study-plans/863eefe3-8c96-4abe-a49e-8317e8bfc2b3 > FDA guidance document: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans. Issue date: July 31, 2020. Get complete insights and analysis. --- ## Details - Title: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans - Communication Type: Guidance Document - Product Type: biologics - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2020-07-31 - Last Changed: 2024-04-11 - Docket Number: FDA-2013-D-0814 ## Related Documents - [Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/limited-population-pathway-for-antibacterial-and-antifungal-drugs-guidance-for-industry/f01d33af-ed26-4eb5-961a-03e00c90f2c7) - [Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients](https://www.globalkeysolutions.net/guidances/guidance-document/cancer-clinical-trial-eligibility-criteria-minimum-age-considerations-for-inclusion-of-pediatric-patients/3666fbd1-9a8e-4d1e-bc77-6f3feec9ce81) - [Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff](https://www.globalkeysolutions.net/guidances/guidance-document/qualification-process-for-drug-development-tools-guidance-for-industry-and-fda-staff/f5a3f8af-54f6-44ba-9eea-d3cc587444f7)