Handbook List

Cost

11 - Electronic Records (ERES) w/ “Scope and Applications”

$3.20

11 & 58 - Part 11 w/Scope & App. &  58 (GLP)

$5.95

11 w/Scope & App. &  Preambles

$6.90

11 & 110 - Electronic Records with Food GMPs

$5.95

11 & 111 - Electronic Records with Dietary Supplement GMPs

$6.95

11 & 210/211 ERES & Drug GMPs

$5.95

11, 203 & 205 - Prescription Drug Marketing

$5.95

11 & 210/211 w/ Keyword Index

$6.90

11, 210/211 & 820 ERES, Drug GMPs & QSRs

$6.90

11 & 820 Electronic Record and Quality Systems

$5.95

11 & Computerized Systems used in Clinical Trials

$5.95

11 & the GMP Part 11 Check Lis

$5.95

13 Public Hearing Before a Public Board of Inquiry

$3.20

50, 54 & 56 Clinical Basic Combo Handbook

$5.95

50 - Protection of human subjects

$3.20

54 - Financial disclosure by clinical investigators

$3.20

56 - Institutional Review Boards

$3.20

58 - Good Laboratory Practice GLPs

$3.20

101 - Food Labeling - 100 book minimum - Call for availability

$16.95

110 - Good Manufacturing Practice for Food Industry

$3.20

111 - Good Manufacturing Practice for Dietary Supplements

$5.95

200 - General (Drug GMPs)

$3.20

201 – Labeling for Drug Industry

$6.90

203 - Prescription Drug Marketing

$3.20

205 - State Lic. of Wholesale Prescription Drug Distr

$3.20

210/211 - Drug Industry GMPs

$3.20

210/211 w/ Keyword Index

$5.95

210/211 with Drug Preambles

$9.90

312 - Investigational New Drug Application

$6.90

314 -  Application to the FDA to Market a New Drug

$6.90

316 - Orphan Drugs

$3.20

511 - New Animal Drugs for Investigational Use

$3.20

600, 601, 610 - Biological GMPs

$6.90

600 - Biological products: general

$3.20

601 - Licensing - Biologics

$3.20

606 - Blood Industry GMPs

$3.20

11 & 606 Electronic Systems for Blood Industry

$5.95

607 - Establish Registration for Manufacturing of Human Blood and Blood Products

$3.20

610 - General biological products standards

$3.20

640 - Add. Standards for human blood and blood products

$3.20

660 - Add. Standards for Diagnostic Substances for Lab. Tests

$3.20

680 - Additional Standards for Miscellaneous Products

$3.20

700 - General (Cosmetics)

$3.20

701 - Cosmetic Labeling

$3.20

700 & 701 - Cosmetic Industry

$5.95

Cosmetic GMPs – 11, 210/211, 700, 701 & ‘Is it a Soap or a Drug?’

$6.90

801 - Labeling - Medical Devices

$3.20

803 - Medical Device Reporting

$3.20

806 - Med. Devices; Reports of Corrections & Removal

$3.20

807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices

$3.20

809 - In Vitro Diagnostic Products for Human Use

$3.20

810 - Medical Device Recall Authority

$3.20

812 - Investigational Device Exemptions

$3.20

814 - Premarket Approval of Medical Devices

$3.20

820 - Quality Systems Regulations

$3.20

11 with Scope & Application and Preambles

$6.90

11, 210/211, 606, 820  Combo Blood GMPs and QSRs

$9.90

Standard-GMPs 11, 210, 211, 820 & ICH Q7

$9.90

Multi-US GMPs 11, 58, 210/211, 600, 601, 610  & 820

$9.90

GMP2 - 11, 58, 210/211, 820 & ICH E6

$9.90

Clinical GCP - 11, 50, 54, 56, 312, 314 & ICH E2A & E6

$9.90

Device - 11, 50, 54, 56, 807, 812, 814, 820, 510k & PMA

$9.90

Computerized Systems used in Clinical Trials

$3.20

European Clinical Trials Directive (2001/20/EC)

$3.20

1270 - Human Tissue Intended for Transplantation

$3.20

1271 - Human Cells, Tissues, Cellular and Tissue…

$3.20

Spanish  11 - Electronic Records

$3.20

Spanish  210/211 - Drug GMPs

$3.20

Spanish  820 - QSRs

$3.20

Spanish  110 GMP for Food Industry

$3.20

Spanish Parts 11, 210/211 & 820

$6.90

Spanish Parts 11 & 210/211 – Drug GMPs

$5.95

1270 & 1271 Combination Booklet

$3.20

ICH E2A - Clinical Safety Data Management…

$3.20

ICH E2B(M) - Clinical Safety Data Mgmt

$3.20

ICH E4 - Dose-Response Information…

$3.20

ICH E6 - Good Clinical Practice

$3.20

ICH E8 - Gen Considerations for Clinical Trials

$3.20

ICH M3 - Timing of Pre-clinical Studies…

$3.20

ICH Q1A - Stability Testing of New Drug…

$3.20

ICH Q1E - Evaluation of Stability Data

$3.20

ICH Q2B - Validation of Analytical Procedures

$3.20

ICH Q5A - Viral Safety Eval. of Biotech…

$3.20

ICH Q5E - Comparability of …

$3.20

ICH Q7 - Good Manufacturing Practices …

$3.20

ICH Q8 - Pharmaceutical Development

$3.20

ICH Q9 - Quality Risk Management

$3.20

ICH Q8 & Q9 -  Combination

$3.20

ICH S2A - Guidance - Reg. Test for Pharma...

$3.20

ICH S6 - Preclinical Safety Evaluation…

$3.20

ICH S7A - Safety Pharmacology Studies…

$3.20

ICH E2A & E2B

$3.20

PMA & 510k Medical Device Guidance Manual

$5.95

Drug Approval Handbook - 312, 314 & 511

$6.90