Regulatory & GLP Resources
These resources are under development and we plan to add more soon, so please check back. We welcome your feedback, contributions, questions, criticism, and suggestions for further additions—send us email to: feedback@thinkboneconsulting.com.
Presentation
Meeting the requirements of FDA GLP guidelines is challenging, but there are good reasons to implement some of the basic principles of GLP in any laboratory.
This presentation explains why, and offers some practical advice on getting started. It may be also useful as a refresher for labs that already have a quality system in place.
Presentation: Basic GLP Training (1 MB)
Link Categories
The links below are grouped into the following categories:
FDA/EMEA Guidelines—Links to regulatory information relevant to bone and animal models
GLP Guidelines
FDA Software Validation & Electronic Records Information
FDA/EMEA Guidelines
Links to regulatory information relevant to bone and animal models
Osteoporosis
GUIDELINES FOR PRECLINICAL AND CLINICAL EVALUATION OF AGENTS USED IN THE PREVENTION OR TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
http://www.fda.gov/cder/guidance/osteo.pdf
EMEA GUIDELINE ON THE EVALUATION OF NEW MEDICINAL PRODUCTS IN THE TREATMENT OF PRIMARY OSTEOPOROSIS
http://www.emea.europa.eu/pdfs/human/ewp/055295en.pdf
Guidance for Industry. Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis.
http://www.fda.gov/cder/guidance/3789dft.pdf
Arthritis
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)
http://www.fda.gov/cder/guidance/2199dft.htm
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)
http://www.fda.gov/cder/guidance/1208fnl.htm
Devices
Regulatory info concerning medical devices – FDA
http://www.fda.gov/cdrh/devadvice/
Animal Models
Draft Guidance: Animal Models — Essential Elements to Address Efficacy Under the Animal Rule
http://www.fda.gov/cder/guidance/8324dft.pdf
GLP Guidelines
CFR Title 21 Part 58 GLP for nonclinical laboratory studies
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html
Comparison chart FDA/EPA/OECD GLP Guidelines
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/definitions.html
FDA Software Validation & Electronic Records Information
General Principles of Software Validation; Final Guidance for Industry and FDA Staff. USDHHS/FDA January 11, 2002.
http://www.fda.gov/cdrh/comp/guidance/938.pdf
21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. USDHHS/FDA March 20, 1997.
http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf
Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application. USDHHS/FDA August 2003. http://www.fda.gov/cder/guidance/5667fnl.pdf
FDA Glossary of Computerized System and Software Development Terminology, August 1995.
http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074875.htm
Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use
in Medical Devices. USDHHS/FDA September 9, 1999.
http://www.fda.gov/cdrh/ode/guidance/585.pdf
Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. USDHHS/FDA May 11, 2005.
http://www.fda.gov/cdrh/ode/guidance/337.pdf