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The Most-Trusted Regulations & Guidelines Books on the Market.
Celebrating 19 Years of Excellence.


Now shipping orders for our April 1, 2020 Books

Also accepting PRE-ORDERS for our REVISED APRIL 1, 2021 BOOKS shipping in May.

All Books

Book CG1: 2020 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials

Book CG1: 2020 Comprehensive Clinical Research Desk Reference for Drug and Medical Device Trials

$ 44.95
21 CFR Parts 1-99, as of April 1, 2020

21 CFR Parts 1-99, as of April 1, 2020

$ 45.00
21 CFR Parts 200-299, as of April 1, 2020

21 CFR Parts 200-299, as of April 1, 2020

$ 20.00

21 CFR Parts 300-499, as of April 1, 2020

21 CFR Parts 300-499, as of April 1, 2020

$ 35.00
Book 1A: 2020 Selected Regulations & Guidance for Drug Studies

Book 1A: 2020 Selected Regulations & Guidance for Drug Studies

$ 16.95
Book 1B: 2020 FDA Good Clinical Practice Guide

Book 1B: 2020 FDA Good Clinical Practice Guide

$ 16.95

Book 2: 2020 Selected Regulations and Guidance for Medical Device Studies

Book 2: 2020 Selected Regulations and Guidance for Medical Device Studies

$ 16.95
Book 3A: 2020 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities

Book 3A: 2020 Selected Regulations and Guidance on Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities

$ 15.95
Book 3B: 2020 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research

Book 3B: 2020 Selected Documents on International Ethical Conduct, Federalwide Assurances, & OHRP Compliance in Academic Research

$ 15.95

Book 3C: 2020 The Official Investigator's Handbook for Conducting Cancer Clinical Trials

Book 3C: 2020 The Official Investigator's Handbook for Conducting Cancer Clinical Trials

$ 15.95
Book 3D: 2020 Common Terminology Criteria for Adverse Events (CTCAE)

Book 3D: 2020 Common Terminology Criteria for Adverse Events (CTCAE)

$ 11.95
Book 4: 2020 Selected Regulations/Guidance on Good Manufacturing Practice

Book 4: 2020 Selected Regulations/Guidance on Good Manufacturing Practice

$ 16.95

Book 4B: 2020 International Reference on Cleaning Validation under Good Manufacturing Practice

Book 4B: 2020 International Reference on Cleaning Validation under Good Manufacturing Practice

$ 16.95
Book 4C: 2020 Good Manufacturing Practice in the European Union, Reference Guide

Book 4C: 2020 Good Manufacturing Practice in the European Union, Reference Guide

$ 15.95
Book 5A: 2020 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance

Book 5A: 2020 Administrative Simplification Provisions of HIPAA: The Act, Regulations and DHHS (OCR) Guidance

$ 15.95

Book 5B: 2020 HIPAA Privacy for Researchers: Guidance from the NIH

Book 5B: 2020 HIPAA Privacy for Researchers: Guidance from the NIH

$ 15.95
Book 6: 2020 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki

Book 6: 2020 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki

$ 15.95
Book 7: 2020 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling

Book 7: 2020 Selected Laws/Regulations/Guidance on Drug Marketing, Advertising, and Labeling

$ 15.95

Book 8: 2020 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

Book 8: 2020 Clinical Research Dictionary & Introduction to the FDA Drug Approval Process

$ 15.95
Book 9: 2020 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

Book 9: 2020 Regulations/Guidance on Good Laboratory Practice and Nonclinical Research

$ 15.95
Book 10: 2020 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice

Book 10: 2020 Selected Regulations/Guidance on Biologics, Blood Products and Good Tissue Practice

$ 15.95

Book 11: 2020 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada

Book 11: 2020 Clinical Research Guide for Drugs, Devices, and Natural Health Products in Canada

$ 15.95
Book 12: 2020 Selected Regulations/Guidance on GCP in India

Book 12: 2020 Selected Regulations/Guidance on GCP in India

$ 15.95
Book 13: 2020 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials

Book 13: 2020 FDA Guidance on Clinical Study Reports and Statistical Principles for Clinical Trials

$ 15.95

Book 14: 2020 Selected Recently-Finalized FDA Guidance Documents

Book 14: 2020 Selected Recently-Finalized FDA Guidance Documents

$ 15.95
Book 16: 2020 Preambles to Good Clinical Practice Regulations

Book 16: 2020 Preambles to Good Clinical Practice Regulations

$ 26.95
Book 17: 2020 Preambles to Good Manufacturing Practice Regulations

Book 17: 2020 Preambles to Good Manufacturing Practice Regulations

$ 22.95

Book 18: SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval

Book 18: SPANISH LANGUAGE ICH Guideline for GCP & FDA CDER Handbook on Drug Approval

$ 15.95
Book 19: 2020 Preambles to Good Laboratory Practice Regulations

Book 19: 2020 Preambles to Good Laboratory Practice Regulations

$ 22.95
Book 20: 2020 ORI Introduction to the Responsible Conduct of Research

Book 20: 2020 ORI Introduction to the Responsible Conduct of Research

$ 15.95

Book 21: 2020 Pharmaceutical Administration, Regulations, and Drug Development in Japan

Book 21: 2020 Pharmaceutical Administration, Regulations, and Drug Development in Japan

$ 15.95
Book 22: 2020 Frequently Asked Questions and Guidance on Clinical Research from the OHRP

Book 22: 2020 Frequently Asked Questions and Guidance on Clinical Research from the OHRP

$ 15.95
Book 23: 2020 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

Book 23: 2020 Part 11 & Drug Development: Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures

$ 15.95

Book 24: European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use

Book 24: European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use

$ 15.95
Book 24A: EU 2020 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules

Book 24A: EU 2020 Guideline on Good Pharmacovigilance Practices, Vol. I: Modules

$ 26.95
Book 24B: EU 2020 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes

Book 24B: EU 2020 Guideline on Good Pharmacovigilance Practices, Vol. II: Annexes

$ 26.95

Book 25: 2020 Laws, Regulations, and Guidance on Pediatric Studies

Book 25: 2020 Laws, Regulations, and Guidance on Pediatric Studies

$ 15.95
Book 26: 2020 People's Republic of China: Selected Laws and Regulations on Drug Research & Good Manufacturing Practice

Book 26: 2020 People's Republic of China: Selected Laws and Regulations on Drug Research & Good Manufacturing Practice

$ 15.95
Book 27: 2020 FDA Investigations Operations Manual

Book 27: 2020 FDA Investigations Operations Manual

$ 29.95

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

$ 17.95
Book 29: 2020 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans

Book 29: 2020 Canadian TRI -COUNCIL POLICY STATEMENT Ethical Conduct for Research Involving Humans

$ 17.95
Book M1: 2020 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A)

Book M1: 2020 Mini Pocket-Sized (3" x 5") ICH Guidelines for GCP (E6) and Clinical Safety Data Management (E2A)

$ 10.95

Book M2: 2020 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312 (Does not include Part 314 or any ICH Guidelines)

Book M2: 2020 Mini Pocket-Sized (3" x 5") Code of Federal Regulations on Good Clinical Practice, 21 CFR Parts 11, 50, 54, 56, 312 (Does not include Part 314 or any ICH Guidelines)

$ 10.95
Book M4: 2020 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary

Book M4: 2020 Mini Pocket-Sized (3" x 5") Clinical Research Dictionary

$ 10.95