Useful Links
1 |
U.S. Food and Drug Administration |
News, Guidance Documents, Dockets, Code of Federal Regulations, and International Activities |
2 |
Guidance Documents from FDA Centers |
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3 |
Center for Biologics Evaluation and Research Publications |
http://www.fda.gov/cber/publications.htm Compliance Program Guides, Information Sheets, Guidance, and Guidelines. |
5 |
Centers for Disease Control and Prevention |
News, Health Topics, Data and Statistics, and Publications |
6 |
United States National Library of Medicine |
Health Information, Library Services, and Research |
7 |
National Institutes of Health |
News, Health Information, and Scientific Resources |
8 |
National Institute of Standards and Technology |
Standards, Quality Guidelines, NIST Research Library, Publications |
9 |
ASTM International Standards |
A non-profit organization that provides a global forum for the development and publication of voluntary consensus standards for materials, products, systems, and services. |
10 |
International Society For Pharmaceutical Engineering |
Industry News, Regulatory Resources, Forums, Training and Education |
11 |
Parenteral Drug Association |
A non-profit organization that promotes the exchange of rapidly evolving information on the latest technology and regulations concerning high-quality pharmaceutical production. |
12 |
American Society for Microbiology |
The world's largest scientific organization of individuals interested in the microbiological sciences. |
13 |
Institute of Validation Technology |
An organization dedicated to expanding the global knowledge base for validation and compliance professionals in FDA-regulated industries. |
14 |
Biospace |
www.biospace.com |
15 |
USP |
www.usp.org |
16 |
Food Drug and Law Institute |
www.fdli.org |
17 |
American Society for Quality |
www.asq.org |
18 |
FDA Code of Federal Regulations Title 21 - Food and Drugs |
www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121 |
19 |
FDA Guideline for Computerized Systems Used in Clinical Trials |
www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm |
20 |
FDA Guideline for General Principals of Software Validation (Draft Guidance v1.1) |
www.fda.gov/cdrh/comp/guidance/938.html |
21 |
Office of Regulatory Affairs Compliance References |
www.fda.gov/ora/compliance_ref/ |
22 |
FDA Warning Letters |
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23 |
FDA Inspection Guides |
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24 |
FDA Guidance Documents |
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25 |
Medical Devicelink |
www.devicelink.com |
26 |
Clinical Trials |
www.clinicaltrials.gov |