Websites of Interest

FDA Links

Archiving Submissions in Electronic Format
www.fda.gov/cder/guidance/arcguide.pdf

Bioresearch Monitoring Information System File: Clinical Investigators, CROs and IRBs from FDA 1571 & 1572s
www.fda.gov/cder/foi/special/bmis/index.htm

CDER Guidance Documents
www.fda.gov/cder/guidance/index.htm

CDER Organizational Chart
www.fda.gov/cder/cderorg.htm

CDRH Device Advice
www.fda.gov/cdrh/devadvice/

CDRH Organization Structure
www.fda.gov/cdrh/organiz.html

Clinical Investigator Disqualifications Proceedings
http://www.fda.gov/foi/clinicaldis/

Computerized Systems Used in Clinical Trials
http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.doc

Drug Approvals List
http://www.fda.gov/cder/da/da.htm

Electronic Regulatory Submissions and review
http://www.fda.gov/cder/regulatory/ersr

Expedited Safety Reporting Requirements Oct 7, 1997 Federal Register Final Rule
http://www.fda.gov/cder/regulatory/
click on: (federal register - GPO)(Federal register)(1997)final rule:regulations)enter date: (on 10/07/1997) search terms: (expedited)

FDA Debarred Persons List
http://www.fda.gov/ora/compliance_ref/debar/

FDA Disqualified/Restricted/Assurances List for Clinical Investigators
http://www.fda.gov/ora/compliance ref/bimo/dis res assur.htm

FDADockets
www.fda.gpv/ohrms/dockets/

FDA Letters Providing Clinical Investigators with Notice of Initiation of Disqualification Proceedings and Opportunity to Explain
www.fda.gov/foi/nidpoe/default.html

FDA Modernization Act of 1997
www.fda.gov/cder/guidance/105-115.htm

CDRH Guidance
www.fda.gov/cdrh/modact/modguid.html

CDER-Related Documents
www.fda.gov/cder/fdama/

FD&C Act
www.fda.gov/opacom/laws/fdcact/fdctoc/htm

Freedom of Information Reading Room
www.fda.gov/foi/

Information for Health Professionals
www.fda.gov/oc/oha

International Conference on Harmonisation
www.fda.gov/cder/guidance/guidance.htm#International Conference on Harmonisation

Investigational Human Drugs Clinical Investigator Inspection List
www.fda.gov/cder/regulatory/investigators/default.htm

Investigational Device Exemptions (IDE) Policies and Procedures
www.fda.gov/cdrh/ode.idepolcy.pdg

Laws Enforced by FDA
www.fda.gov/opacom/laws/lawtoc.htm

MedWatch
www.fda.gov/medwatch/

National Drub Code (NDC) directory
www.fda.gov/cder/ndc/

New Drug Approval Packages
www.fda.gov/cder/foi/nda/

Orange Book (Approved Drugs)
www.fda.gov/cder/orange/adp.htm

Pediatric Medicine Page
www.fda.gov/cder/pediatric/

Pharmacy Compounding
www.fda.gov/cder/pharmcomp/

Warning letters
www.fda.gov/foi/warning.htm

CDER Bioresearch Monitoring
www.fda.gov/cdrh/comp/bimo.html

Non-FDA Links

Clinical Trials Registry
www.clinicaltrials.gov

Government Printing Office (Federal Register, Code of Federal Regulations, Congressional Record)
www.access.gpo.gov/su docs/

HHS Employee and Organizational Directory
directory.psc.gov

Institute of Medicine of the National Academy of Sciences
www.iom.edu/IOM/IOMHome.nsf/Pages/human+research+protection

National Bioethics Advisory Committee
bioethics.gov/cgi-bin/bioeth counter.pl

National Human Research Protections Advisory Committee
ohrp.osophs.dhhs.gov/nhrpac/nhrpac.htm

Office for Human Research Protections
ohrp.osophs.dhhs.gov

OHRP IRB Guidebook
ohrp.osophs.dhhs.gov/irb/irb guidebook.htm

PHS List of Investigators Subject to Administrative Action:
Silk.nih.gov/public/cbzlbje.@www.orilist.html

Veterans' Administration Office of Research Compliance and Assurance (ORCA)
www.va.gov/orca/

Industry Links

FDA - U.S. Food and Drug Administration
www.fda.gov

CENTERWATCH - Clinical Trials Listing Service
www.centerwatch.com

DIA - Drug Information Association
www.diahome.org

PERI - Pharmaceutical Education & Research Institute
www.peri.org

ACRP - Association of Clinical Research Professionals
www.acrpnet.org