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Celebrating 24 YEARS of Regulatory Excellence!
Go with the Most-Trusted Regulations & Guidelines Books on the Market.
Now taking Pre-Orders for our April 1, 2026 Books, shipping in mid-May. Check out our Books with the
FDA-Approved E6(R3) GOOD CLINICAL PRACTICE GUIDANCE
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PRE-ORDER April 1, 2026 Books
(Shipping in mid-May)
+
>Select from All 2026 Books
>Drug Studies, Good Clinical Practice
>Medical Devices
>Good Manufacturing Practice
>CTCAE Books
>HIPAA Books
>Laboratory and CLIA
>International Books
>Biological Products
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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
(With FDA/ICH GCP E6(R3))
$ 25.95
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
(With FDA/ICH GCP E6(R3))
$ 25.95
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
$ 23.95
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)
$ 19.95
Book 4: 2026 Selected Regulations/Guidance on Good Manufacturing Practice
$ 18.95
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
$ 18.95
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
$ 17.95
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
$ 18.95
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
$ 18.95
Book 16: 2026 Preambles to Good Clinical Practice Regulations
$ 28.95
Book 17: 2026 Preambles to Good Manufacturing Practice Regulations
$ 24.95
Book 19: 2026 Preambles to Good Laboratory Practice Regulations
$ 22.95
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
$ 17.95
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
$ 17.95
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
$ 14.95
Book M4: 2026 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary
$ 14.95
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