FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec 505B of the FD&C Act: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
May 24, 2021
April 11, 2024
7a11011d-8bb1-46e2-8382-c4460aea8ec8
Related Documents
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Guidance DocumentMay 26, 2023Center for Drug Evaluation and Research
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry
Guidance DocumentMarch 1, 2022Center for Drug Evaluation and Research
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry
Guidance DocumentMarch 1, 2022Center 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.