U.S. Food & Drug Administration Resources

U.S. FDA website
http://www.fda.gov/

FDA introductory video-based training program regarding the new-drug pre-marketing approval process. http://www.connectlive.com/events/drugdev/viewvideos.html#

FDA outreach to small businesses.
http://www.fda.gov/cder/about/smallbiz/default.htm

FDA Guidance documents with recommendations to industry
regarding compliance.
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm

The Code of Federal Regulations can be searched for regulations applicable to Pharmaceutical, Biologics, Blood Products, and Biotechnology Products.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
cfrsearch.cfm

Industry Organizations

International Society for Pharmaceutical Engineering (ISPE)
ISPE has collaborated with the FDA to produce guides for engineering / facility aspects of regulatory compliance. ISPE also provides training courses in cGMP compliance, engineering design and validation.
http://www.ispe.org

AAPS Pharmaceutica (American Association of Pharmaceutical Scientists)
Listing of local discussion groups.
http://www.aapspharmaceutica.com/inside/Discussion_
Groups/index.asp

The Bioscience Forum
http://www.biosf.org/

The Biotech Industry Organization
http://www.bio.org/

The American Society for Quality
http://www.asq.org/

The Parenteral Drug Association
http://www.pda.org/

The Regulatory Affairs Professionals Society
http://www.raps.org/s_raps/index.asp

Biopharm International provides journal articles and more useful links
http://www.biopharminternational.com/biopharm/