Handbook List

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

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

11 w/Scope & App. &  Preambles

11 & 110 - Electronic Records with Food GMPs

11 & 111 - Electronic Records with Dietary Supplement GMPs

11 & 210/211 ERES & Drug GMPs

11, 203 & 205 - Prescription Drug Marketing

11 & 210/211 w/ Keyword Index

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

11 & 820 Electronic Record and Quality Systems

11 & Computerized Systems used in Clinical Trials

11 & the GMP Part 11 Check List

13 Public Hearing Before a Public Board of Inquiry

50, 54 & 56 Clinical Basic Combo Handbook

50 - Protection of human subjects

54 - Financial disclosure by clinical investigators

56 - Institutional Review Boards

58 - Good Laboratory Practice GLPs

101 - Food Labeling - 2 book min.

110 - Good Manufacturing Practice for Food Industry

111 - Good Manufacturing Practice for Dietary Supplements

200 - General (Drug GMPs)

201 – Labeling for Drug Industry

203 - Prescription Drug Marketing

205 - State Lic. of Wholesale Prescription Drug Distr

203 & 205 with Part 11 - Prescription Drug Marketing

210/211 - Drug Industry GMPs

210/211 w/ Keyword Index

210/211 with Drug Preambles

312 - Investigational New Drug Application

314 -  Application to the FDA to Market a New Drug

316 - Orphan Drugs

511 - New Animal Drugs for Investigational Use

600, 601, 610 - Biological GMPs

600 - Biological products: general

601 - Licensing - Biologics

606 - Blood Industry GMPs

606 & 11 Electronic Systems for Blood Industry

607 - Estab Reg for Manuf of Human Blood and Blood Products

610 - General biological products standards

640 - Add. Standards for human blood and blood products

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

680 - Additional Standards for Miscellaneous Products

700 - General (Cosmetics)

701 - Cosmetic Labeling

700 & 701 - Cosmetic Industry

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

801 - Labeling - Medical Devices

803 - Medical Device Reporting

806 - Med. Devices; Reports of Corrections & Removal

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

809 - In Vitro Diagnostic Products for Human Use

810 - Medical Device Recall Authority

812 - Investigational Device Exemptions

814 - Premarket Approval of Medical Devices

820 - Quality Systems Regulations

11 with Scope & Application and Preambles

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

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

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

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

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

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

Computerized Systems used in Clinical Investigations

European Clinical Trials Directive (2001/20/EC)

1270 - Human Tissue Intended for Transplantation

1271 - Human Cells, Tissues, Cellular and Tissue…

1270 & 1271 Combination Booklet

Spanish  11 - Electronic Records

Spanish  210/211 - Drug GMPs

Spanish  820 - QSRs

Spanish  110 GMP for Food Industry

Spanish Parts 11, 210/211 & 820

Spanish Parts 11 & 210/211 – Drug GMPs

ICH E2A - Clinical Safety Data Management…

ICH E2B(M) - Clinical Safety Data Mgmt

ICH E4 - Dose-Response Information…

ICH E6 - Good Clinical Practice

ICH E8 - Gen Considerations for Clinical Trials

ICH M3 - Timing of Pre-clinical Studies…

ICH Q1A - Stability Testing of New Drug…

ICH Q1E - Evaluation of Stability Data

ICH Q2B - Validation of Analytical Procedures

ICH Q5A - Viral Safety Eval. of Biotech…

ICH Q5E - Comparability of …

ICH Q7 - Good Manufacturing Practices …

ICH Q8 - Pharmaceutical Development

ICH Q9 - Quality Risk Management

ICH Q8 & Q9 -  Combination

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

ICH S6 - Preclinical Safety Evaluation…

ICH S7A - Safety Pharmacology Studies…

ICH E2A & E2B

PMA & 510k Medical Device Guidance Manual

Drug Approval Handbook - 312, 314 & 511