List of Regulatory Affairs & Quality Assurance Web Links

1. Clinical Data Interchange Standards Consortium (CDISC) (2008), Mission Statement, http://www.cdisc.org/about/index.html
2. European Union – EMEA. (2008). EudraVigilance. http://eudravigilance.emea.europa.eu/human/index.asp
3. European Union – EMEA. (2008). European Medicines Agency Overview. http://www.emea.europa.eu/htms/aboutus/emeaoverview.htm
4. European Union – EMEA. (2008). EURS. http://esubmission.emea.europa.eu/tiges/eurs.htm
5. European Union – EMEA. (2008). EURS:Implementation Timelines. http://eudravigilance.emea.europa.eu/human/index.asp
6. European Union. Medical Device Sector. (1993). Council Directive 93/42/EEC. 14 June 1993. http://ec.europa.eu/enterprise/medical_devices/guide-stds-directives/cons_vers_93-42-eec.pdf
7. Food and Drug Administration, (2008). ANDA Checklist for CTD or eCTD Format, June 23. 2008. http://www.fda.gov/cder/ogd/anda_checklist.doc
8. Food and Drug Administration, CBER, (2006). Lot Distribution Data (LDD) Electronic Submission, 12 May. 2008. http://www.fda.gov/CbER/ldd/ldd.htm
9. Food and Drug Administration, CBER. (2002). Guidance for Industry, Providing Regulatory Submissions to CBER in Electronic Format – Investigational New Drug Applications (INDs). March 2002. http://www.fda.gov/cber/gdlns/eind.pdf
10. Food and Drug Administration, CBER. (2008). Important Information About Digital/Electronic Signatures. http://www.fda.gov/esg/ESG/digital_signatures.htm
11. Food and Drug Administration, CDER, (2008). Office of Generic Drugs, May 28. 2008. http://www.fda.gov/cder/ogd/
12. Food and Drug Administration, CDER, CBER. (1999). Guidance for Industry, Providing Regulatory Submissions in Electronic Format - General Considerations. January 1999. http://www.fda.gov/cder/guidance/2867fnl.pdf
13. Food and Drug Administration, CDER, CBER. (2006). Guidance for Industry, Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the ECTD Specifications. April 2006. http://www.fda.gov/cber/gdlns/esubapp.pdf
14. Food and Drug Administration, CDER, CBER. (2006). Welcome to the FDA AERS Electronic Submissions Web Site. 16 Jan. 2006. http://www.fda.gov/cder/aerssub/default.htm
15. Food and Drug Administration, CDER, CBER. (2007). SPL Release 3 Implementation Guide for FDA Drug and Biological Products V1.1. 11 Jan. 2007. http://www.fda.gov/oc/datacouncil/splr3_Implementation_Guidev1_1.pdf
16. Food and Drug Administration, CDER. (2001). Guidance for Industry, Providing Regulatory Submissions in Electronic Format – Prescription Drug Advertising and Promotional Labeling (PDAPL). January 2001. http://www.fda.gov/cder/guidance/3729dft.pdf
17. Food and Drug Administration, CDER. (2002). Transmittal of Annual Reports for Drugs for Human Use. April 2002. http://www.psc.gov/forms/FDA/FDA-2252.pdf
18. Food and Drug Administration, CDRH. (1997). Title 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. March 20, 1997. http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf
19. Food and Drug Administration, CDRH. (2002). Device Classes. November, 2002. http://www.fda.gov/cdrh/devadvice/3132.html
20. Food and Drug Administration, CDRH. (2002). PreMarket Approval (PMA) - Postapproval Requirements. November 2002. http://www.fda.gov/cdrh/devadvice/pma/postapproval.html
21. Food and Drug Administration, CDRH. (2003). Clinical Trials & Investigational Device Exemption (IDE). August, 2003. http://www.fda.gov/CDRH/DEVADVICE/ide/application.shtml
22. Food and Drug Administration, CDRH. (2005). A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures. November. 2005. http://www.fda.gov/cdrh/ode/guidance/1347.html
23. Food and Drug Administration, CDRH. (2007). Electronic Copies for Pre-Market Submissions. April 2002. 9 Mar. 2008 http://www.fda.gov/cdrh/elecsub.html
24. Food and Drug Administration, CDRH. (2007). eMDR – Electronic Medical Device Reporting. December, 2007. http://www.fda.gov/cdrh/emdr/index.html
25. Food and Drug Administration, CDRH. (2007). Title 21 CFR Part 812 Investigational Device Exemptions. April 2007. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
26. Food and Drug Administration, CDRH. (2008). CeSub eSubmitter. March 2008, http://www.fda.gov/cdrh/cesub/
27. Food and Drug Administration, CDRH. (2008). Drug Master Files (DMF). September 1989. http://www.fda.gov/cder/guidance/dmf.htm
28. Food and Drug Administration, CDRH. (2008). Guidance for Drug Master Files (DMF). April 2008. http://www.fda.gov/cder/dmf/
29. Food and Drug Administration, CDRH. (2008). Guidance on Electronic Regulatory Submissions and Review (ERSR). 28 Feb. 2008. http://www.fda.gov/cder/regulatory/ersr/default.htm
30. Food and Drug Administration, Department of Health and Human Services. (2006). Investigational New Drug Application (IND) Form 1571. April 2006. http://www.fda.gov/opacom/morechoices/fdaforms/1571es.pdf
31. Food and Drug Administration, Department of Health and Human Services. (2005). Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Form 356h. October 2005. http://www.fda.gov/opacom/morechoices/fdaforms/356Hes.pdf
32. Food and Drug Administration, Department of Health and Human Services. (2007). Electronic Submission Gateway (ESG) User Guide. November 21, 2007. http://www.fda.gov/esg/pdf/FDA_ESG_User_Guide_10092007.pdf
33. Food and Drug Administration, Department of Health and Human Services. (2006). FDA Electronic Submissions Gateway (ESG). August 18, 2006. http://www.fda.gov/esg/ESG/default.htm
34. Food and Drug Administration, Department of Health and Human Services. (2007). The FDA Safety Information and Adverse Event Reporting Program - MedWatch. March 2, 2007. http://www.fda.gov/medwatch/report/mfg.htm
35. Food and Drug Administration. (2002). Electronic Secure Messaging v2.0, Working Instructions for Industry – Draft, Center for Biologics Evaluation and Research; Electronic Regulatory Submission and Review, May 6, 2002.
    Food and Drug Administration. (2008). Medical Device User Fee Rates for Fiscal Year 2008. October 12, 2007. http://www.fda.gov/OHRMS/DOCKETS/98fr/07-5051.htm
36. Gensinger, Gary M. (2008). eCTD Submissions. Director, Regulatory Review Support Staff Office of Business Process Support, CDER, FDA. http://www.fda.gov/cder/regulatory/ersr/2008_Feb_7-DIA_ElectronicDMMtg/eCTD_Update.pdf
37. Gensinger, Gary M. (2008). eCTD Update. Director, Regulatory Review Support Staff Office of Business Process Support, CDER, FDA. http://www.fda.gov/cder/regulatory/ersr/2008_Feb_7-DIA_ElectronicDMMtg/eCTD_Update.pdf
38. Global Harmonization Task Force (GHTF). (2008). Principles of Conformity Assessment for Medical Devices. http://www.ghtf.org/documents/sg1/SG1N40%202006-Conformity-Assessment-FINAL.pdf
39. Global Harmonization Task Force (GHTF). (2008). Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED). http://www.ghtf.org/documents/sg1/SG1-PD-N011-sted.pdf
40. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2004). ICH M2 EWG – Electronic Common Technical Document Specification. February 4, 2004. http://estri.ich.org/eCTD/eCTD_Specification_v3_2.pdf