FDA Web sites

FDA Web sites

FDA	http://www.fda.gov/default.htm
CBER	http://www.fda.gov/cber/index.html
CDER	http://www.fda.gov/cder/
CDER Handbook	www.fda.gov/cder/handbook/index.htm
Regulatory Guidance	http://www.fda.gov/cder/guidance/index.htm
FDA Modernization Act of 1997	http://www.fda.gov/cder/fdama/default.htm
CDER Freedom of Information Office	http://www.fda.gov/cder/foi/index.htm
Code of Federal Regulations	http://www.access.gpo.gov/cgi-bin/ cfrassemble.cgi?title=199821
Guidance for Investigational Review Boards and Clinical Investigators	http://www.fda.gov/oc/ohrt/irbs/default.htm
Postmarketing Surveillance And Epidemiology: Human Drugs	http://www.fda.gov/cder/aers/chapter53.htm
FDA Forms Distribution Page for CDER	http://www.fda.gov/opacom/morechoices/ fdaforms/cder.html
Information for Sponsor-Investigators submitting Investigational New Drug Applications	http://www.fda.gov/cder/forms/ 1571-1572-help.html
Drug Approval Application Process	http://www.fda.gov/cder/regulatory/ applications/default.htm
To subscribe or unsubscribe to CDERNEW	http://www.fda.gov/cder/cdernew/listserv.html
Drug Development and Review Definitions	http://www.fda.gov/cder/about/smallbiz/ definitions.htm
CDER Acronym List	http://www.fda.gov/cder/handbook/index.htm
Comprehensive list of all government regulations	http://regsource.com/
Preventable Adverse Drug Reactions	http://www.fda.gov/cder/drug/drugReactions/ default.htm#Sample%20Case
Audit Model	http://www.fda.gov/cder/drug/drugReactions /default.htm#Sample%20Case
Pharmaceutical Research and Manufacturers of America	www.phrma.org
RegSource Regulatory Page	www.regsource.com