Book 25: 2025 Laws, Regulations, and Guidance on Pediatric StudiesDescription Contents Cover This spiral bound, 5" x 7. 5" book is a compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children. It includes the recent revisions from the Food and Drug Administration Amendments Act of 2007 to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), as well as recent guidances on compliance with these Acts and general

It is also used by state offices to administer various federal programs

Part II: Planning Research

• Maximum safe starting dose estimates

5" book includes 21 CFR Part 11

Peer Review

Investigators

Content of Clinical Study Reports

Parts    1    Definition of Terms

and electronic and printed resources

DOCUMENTS ON FDA MEDICAL DEVICE DEVELOPMENT

54   Financial Disclosure

in Research