References and Regulatory Information

Regulatory Databases:

FDA Compliance Program Guidance Manual Database

FDA Guidance Document Database

FDA Warning Letter Database

Regulations and Principles:

FDA Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR Part 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.

FDA Electronic Records; Electronic Signatures, 21 CFR Part 11

FDA Quality System Regulations, 21 CFR Part 820

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring (Consensus Documents)

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FDA Draft Guidance for Industry.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

Bioanalytical Method Validation
FDA Guidance for Industry. May, 2001.

Good Laboratory Practices Questions and Answers
FDA Guidance for Industry. July, 2007.
See also:

Process for Drug Development Tools
FDA Guidance for Industry and FDA Staff Qualification. Jan. 2014.

Product Development Under the Animal Rule
FDA Guidance for Industry. October 2015

Q2B Validation of Analytical Procedures: Methodology
FDA Guidance for Industry. 1996

Text on Validation of Analytical Procedures ICH Q2A
FDA Guidance for Industry, March 1995

Validation of Analytical Procedures: Text and Methodology Q2(R1)
ICH Harmonised Tripartite Guideline. Nov. 2005.

Tools for Regulatory Science:

Advancing Regulatory Science (includes FDA Strategic Plan for Regulatory Science)
FDA Science and Research Special Topic

Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and OECD Principles of GLP

Guidance for Preparing Standard Operating Procedures
EPA QA/G-6, April, 2007

How to Start—and Keep—a Laboratory Notebook: Policy and Practical Guidelines
Jennifer A. Thomson, University of Cape Town, South Africa

Quality System Workbook
Research Quality Association (free download)

Other Helpful Documents and Websites:

FDA Bioresearch Monitoring Information Page

Society of Quality Assurance

FDA Federal Register

The United States Department of Health and Human Services Strategic Plan, Fiscal Years 2010-2015

The United States Department of Health and Human Services Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy