References and Regulatory Information

Regulatory Databases:

FDA Compliance Program Guidance Manual Database
http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/default.htm

FDA Guidance Document Database
http://www.fda.gov/regulatoryinformation/guidances/

FDA Warning Letter Database
http://www.fda.gov/iceci/enforcementactions/WarningLetters/default.htm

Regulations and Principles:

FDA Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 58 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=58

FDA New Drug and Biological Drug Products; Evidence needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible, 21 CFR Parts 314 and 601.
http://www.fda.gov/ohrms/dockets/98fr/053102a.htm

FDA Electronic Records; Electronic Signatures, 21 CFR Part 11 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

FDA Quality System Regulations, 21 CFR Part 820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring (Consensus Documents)
http://www.oecd-ilibrary.org/environment/oecd-series-on-principles-of-good-laboratory-practice-and-compliance-monitoring_2077785x

Selected Guidelines and Guidance Documents:

Animal Models—Essential Elements to Address Efficacy Under the Animal Rule
FDA Guidance for Industry. 2009
PDF document

Bioanalytical Method Validation
FDA Draft Guidance for Industry. Sept. 2013
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf

Bioanalytical Method Validation
FDA Guidance for Industry. May, 2001.
http://www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf

Good Laboratory Practices Questions and Answers
FDA Guidance for Industry. July, 2007. http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/ucm133748.pdf
See also: http://www.fda.gov/ICECI/Inspections/NonclinicalLaboratoriesInspectedunderGoodLaboratoryPractices/ucm072738.htm

Process for Drug Development Tools
FDA Guidance for Industry and FDA Staff Qualification. Jan. 2014.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf

Product Development Under the Animal Rule
FDA Guidance for Industry. October 2015
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM399217.pdf

Q2B Validation of Analytical Procedures: Methodology
FDA Guidance for Industry. 1996
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf

Text on Validation of Analytical Procedures ICH Q2A
FDA Guidance for Industry, March 1995
http://www.fda.gov/downloads/Drugs/Guidances/ucm073381.pdf

Validation of Analytical Procedures: Text and Methodology Q2(R1)
ICH Harmonised Tripartite Guideline. Nov. 2005.
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf

Tools for Regulatory Science:

Advancing Regulatory Science (includes FDA Strategic Plan for Regulatory Science)
FDA Science and Research Special Topic http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/default.htm?utm_campaign=Goo

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and OECD Principles of GLP
http://www.fda.gov/iceci/enforcementactions/bioresearchmonitoring/ucm135197.htm

Guidance for Preparing Standard Operating Procedures
EPA QA/G-6, April, 2007
http://www.epa.gov/QUALITY/qs-docs/g6-final.pdf

How to Start—and Keep—a Laboratory Notebook: Policy and Practical Guidelines
Jennifer A. Thomson, University of Cape Town, South Africa
http://www.iphandbook.org/handbook/ch08/p02/

Quality System Workbook
Research Quality Association (free download)
http://www.therqa.com/publications/quality-systems-workbook/

Other Helpful Documents and Websites:

FDA Bioresearch Monitoring Information Page
http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm

Society of Quality Assurance
www.sqa.org

FDA Federal Register
http://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR

The United States Department of Health and Human Services Strategic Plan, Fiscal Years 2010-2015
http://www.hhs.gov/secretary/about/priorities/strategicplan2010-2015.pdf

The United States Department of Health and Human Services Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy http://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Strategy.pdf