Book 25: 2026 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

• Chapter 5: Production

•  Monitoring Good Laboratory Practice: Compliance Manual

•  Excerpt From The Patient Protection and Affordable Care

Please note that this book does NOT contain the sections of 21 CFR Part 314 on New Drug Applications (NDAs)

• Care and Handling of Laboratory Animals

•   FDA Guidance:  Process for Handling Referrals

REGULATIONS AND INTERPRETIVE GUIDELINES FOR LABORATORIES AND LABORATORY SERVICES

The SOM is a source of guidance to laboratories for interpreting the CLIA regulations

• Questions and Answers (R1) on ICH E3: Structure and

It includes all of 21 CFR Part 314 on NDAs and the ICH GCP Guideline E6(R3)

November 9

a review of the processes for obtaining FDA approval to market drugs