Useful FDA links

The following links relating to the U.S. Food and Drug Administration (FDA) may be of interest to readers.

 

FDA Home Page: http://www.fda.gov/default.htm

 

FDA GMP Regulations (CFR21): http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr211_ 01.html

 

FDA Inspections Operation Manual: http://www.fda.gov/ICECI/Inspections/IOM/default.htm  

 

FDA Inspection Guides: http://www.fda.gov/ora/inspect_ref/igs/iglist.html  

 

FDA CBER Guidance / Guidelines / Points to Consider: http://www.fda.gov/cber/guidelines.htm  

 

FDA Guidance on Drugs:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor mation/Guidances/default.htm

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)