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Celebrating 24 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.


Now taking orders for our April 1, 2026 Books!     Check out our Books with the FDA-Approved E6(R3) GOOD CLINICAL PRACTICE GUIDANCE       

All Books

Book CG1: 2026 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>

Book CG1: 2026 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials (With FDA/ICH GCP E6(R3))

$ 46.95
Book 1A: 2026 Selected Regulations & Guidance for Drug Studies <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>

Book 1A: 2026 Selected Regulations & Guidance for Drug Studies (With FDA/ICH GCP E6(R3))

$ 25.95
Book 1B: 2026 FDA Good Clinical Practice Guide <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>

Book 1B: 2026 FDA Good Clinical Practice Guide (With FDA/ICH GCP E6(R3))

$ 26.95

Book 1C: 2026 Good Clinical Practice Regulations in the US & the EU <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>

Book 1C: 2026 Good Clinical Practice Regulations in the US & the EU (With FDA/ICH GCP E6(R3))

$ 25.95
Book 2: 2026 Selected Regulations and Guidance for Medical Device Studies <span style="color: #b70202">(With FDA/ICH GCP E6(R3))</span>

Book 2: 2026 Selected Regulations and Guidance for Medical Device Studies (With FDA/ICH GCP E6(R3))

$ 21.95
Book 3A: 2026 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities

Book 3A: 2026 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities

$ 23.95

Book 3D v5.0: Version 5.0 Common Terminology Criteria for Adverse Events (CTCAE)

Book 3D v5.0: Version 5.0 Common Terminology Criteria for Adverse Events (CTCAE)

$ 16.95
Book 3D v6.0: Version 6.0 Common Terminology Criteria for Adverse Events (CTCAE)

Book 3D v6.0: Version 6.0 Common Terminology Criteria for Adverse Events (CTCAE)

$ 19.95
Book 4: 2026 Selected Regulations/Guidance on Good Manufacturing Practice

Book 4: 2026 Selected Regulations/Guidance on Good Manufacturing Practice

$ 18.95

Book 4C: 2026 Good Manufacturing Practice in the European Union, Reference Guide

Book 4C: 2026 Good Manufacturing Practice in the European Union, Reference Guide

$ 18.95
Book 5A: 2026 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance

Book 5A: 2026 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance

$ 18.95
Book 5B: 2026 HIPAA Privacy for Researchers: Guidance from the NIH

Book 5B: 2026 HIPAA Privacy for Researchers: Guidance from the NIH

$ 17.95

Book 8: 2026 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

Book 8: 2026 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

$ 17.95
Book 9: 2026 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

Book 9: 2026 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

$ 17.95
Book 10: 2026 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice

Book 10: 2026 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice

$ 18.95

Book 13: 2026 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy)

Book 13: 2026 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials (Copy)

$ 17.95
Book 14: 2026 Selected Recently-Finalized FDA Guidance Documents

Book 14: 2026 Selected Recently-Finalized FDA Guidance Documents

$ 18.95
Book 16: 2026 Preambles to Good Clinical Practice Regulations

Book 16: 2026 Preambles to Good Clinical Practice Regulations

$ 28.95

Book 17: 2026 Preambles to Good Manufacturing Practice Regulations

Book 17: 2026 Preambles to Good Manufacturing Practice Regulations

$ 24.95
Book 19: 2026 Preambles to Good Laboratory Practice Regulations

Book 19: 2026 Preambles to Good Laboratory Practice Regulations

$ 22.95
Book 20: 2026 ORI Introduction to the Responsible Conduct of Research

Book 20: 2026 ORI Introduction to the Responsible Conduct of Research

$ 17.95

Book 22: 2026 Frequently Asked Questions and Guidance on Clinical Research from the OHRP

Book 22: 2026 Frequently Asked Questions and Guidance on Clinical Research from the OHRP

$ 17.95
Book 23: 2026 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

Book 23: 2026 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

$ 17.95
Book 25: 2026 Laws, Regulations, and Guidance on Pediatric Studies

Book 25: 2026 Laws, Regulations, and Guidance on Pediatric Studies

$ 17.95

Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines

Book 28: Clinical Laboratory Improvement Amendments of 1988 (CLIA): Survey Procedures and Interpretive Guidelines

$ 24.95
Book M2: 2026 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312

Book M2: 2026 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312

$ 14.95
Book M4: 2026 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary

Book M4: 2026 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary

$ 14.95