Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
July 31, 2020
April 11, 2024
863eefe3-8c96-4abe-a49e-8317e8bfc2b3
Related Documents
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
Guidance DocumentAugust 5, 2020Center for Drug Evaluation and Research
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
Guidance DocumentJuly 10, 2020Center for Drug Evaluation and Research
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff
Guidance DocumentNovember 24, 2020Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.