Information Links

Following are some of the important quality assurance and regulatory affairs web links containing information about laws, guidance documents and standards.

List of Regulatory Affairs & Quality Assurance Web Links

Clinical Data Interchange Standards Consortium (CDISC) (2008), Mission Statement, http://www.cdisc.org/about/index.html
European Union – EMEA. (2008). EudraVigilance. http://eudravigilance.emea.europa.eu/human/index.asp
European Union – EMEA. (2008). European Medicines Agency Overview. http://www.emea.europa.eu/htms/aboutus/emeaoverview.htm
European Union – EMEA. (2008). EURS. http://esubmission.emea.europa.eu/tiges/eurs.htm
European Union – EMEA. (2008). EURS:Implementation Timelines. http://eudravigilance.emea.europa.eu/human/index.asp
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
Food and Drug Administration, (2008). ANDA Checklist for CTD or eCTD Format, June 23. 2008. http://www.fda.gov/cder/ogd/anda_checklist.doc
Food and Drug Administration, CBER, (2006). Lot Distribution Data (LDD) Electronic Submission, 12 May. 2008. http://www.fda.gov/CbER/ldd/ldd.htm
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
Food and Drug Administration, CBER. (2008). Important Information About Digital/Electronic Signatures. http://www.fda.gov/esg/ESG/digital_signatures.htm
Food and Drug Administration, CDER, (2008). Office of Generic Drugs, May 28. 2008. http://www.fda.gov/cder/ogd/
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
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
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
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
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
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
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
Food and Drug Administration, CDRH. (2002). Device Classes. November, 2002. http://www.fda.gov/cdrh/devadvice/3132.html
Food and Drug Administration, CDRH. (2002). PreMarket Approval (PMA) - Postapproval Requirements. November 2002. http://www.fda.gov/cdrh/devadvice/pma/postapproval.html
Food and Drug Administration, CDRH. (2003). Clinical Trials & Investigational Device Exemption (IDE). August, 2003. http://www.fda.gov/CDRH/DEVADVICE/ide/application.shtml
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
Food and Drug Administration, CDRH. (2007). Electronic Copies for Pre-Market Submissions. April 2002. 9 Mar. 2008 http://www.fda.gov/cdrh/elecsub.html
Food and Drug Administration, CDRH. (2007). eMDR – Electronic Medical Device Reporting. December, 2007. http://www.fda.gov/cdrh/emdr/index.html
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
Food and Drug Administration, CDRH. (2008). CeSub eSubmitter. March 2008, http://www.fda.gov/cdrh/cesub/
Food and Drug Administration, CDRH. (2008). Drug Master Files (DMF). September 1989. http://www.fda.gov/cder/guidance/dmf.htm
Food and Drug Administration, CDRH. (2008). Guidance for Drug Master Files (DMF). April 2008. http://www.fda.gov/cder/dmf/
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
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
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
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
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
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
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
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
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
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
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
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
Kumar, S., & Ghahraman, V. (2007). Electronic Submissions: A Guide for Electronic Regulatory Submissions to the FDA. In D. J. Pisano, & David M. (Eds.), FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (pp. 249-302). CRC Press: Informa Healthcare.
Mathieu M. (1997). New Drug Development: A Regulatory Overview, PAREXEL International Corp, 4th ed., Walthan, MA, 1997.
MCCurdy L., (2000). CBER and Computer Assisted Product License Applications, Chapter 15 in Bilogics Development:A Regulatory Overview, Mathieu M. Ed.,, PAREXEL International Corp, 4th ed., Walthan, MA, 1993.
Ross, R., Galle S., & Collom W., (2000). Regulatory Submissions: From CANDA/CAPLA to 2002 in Beyond Drug Information Journal, Vol 34, 2000, pp. 761-774.

List of Abbreviations and Acronyms

More detail list can be found under web link Regulatory Affairs Abbreviations and Acronyms

Abbreviation	Explanation
510 (k)	Premarket Notification
AERS	Adverse Event Reports
ANADA	Abbreviated New Animal Drug Application
ANDA	Abbreviated New Drug Application
ASCII	American Standard Code for Information Interchange
BLA	Biologic License Application
CA	Competent Authority
CBER	Center for Biologic Evaluation and Research
CDER	Center for Drug Evaluation and Research
CDRH	Center for Devices and Radiological Health
CDISC	Clinical Data Interchange Standards Consortium
CE	Conformité Européenne
CeSub	CDRH electronic submission
CFR	Code of Federal Regulations
cGMP	Current Good Manufacturing Practices
CLIA	Clinical Laboratory Improvements Amendments
CHMP	Committee for Medicinal Products for Human Use
CTA	Clinical Trial Approval
CTD	Common Technical Documentation
DEA	Drug Enforcement Administration
DHHS	Department of Health and Human Services
DMF	Drug Master File
DTD	Document Type Definition
EC	European Commission
ECTD	Electronic Common Technical Document Specification
EDMS	Electronic Database Management System
EFT	Electronic Funds Transfer
ELA	Establishment License Application
EMEA	European Medicines Agency
ESG	Electronic Submission Gateway
EU	European Union
EURS	European Review System
FDA	Food and Drug Administration
FDA	Food and Drug Administration
FDAMA	Food and Drug Administration Modernization Act
FFDCA	Federal Food, Drug, and Cosmetic Act of 1938
GHTF	Global Harmonization Task Force (GHTF)
GIF	Graphics Interchange Format
HDE	Humanitarian Device Exemption
HL7	Health Level 7
ICH	International Conference on Harmonization
IDE	Investigational Device Exemption
INAD	Investigational New Animal Drug
IND	Investigational New Drug
IRB	Institutional Review Board
ISO	International Standards Organization
IUO	Investigational Use Only
IVD	In Vitro Diagnostic
JPEG	Joint Photographic Experts Group
MDD	Medical Device Directive
MDR	Medical Device Reporting
MDUFMA	Medical Devices User Fee and Modernization Act
NADA	New Animal Drug Application
NB	Notified Body
NDA	New Drug Application
NDC	Notational Drug Code
OCP	Office of Combination Products
OCR	Optical Character Recognition
OIVD	Office of Invitro Diagnostic
PDF	Portable Document Format
PDP	Product Development Protocol
PDUFA	Prescription Drug User Fee Act
PLA	Product License Application
PMA	Premarket Approval Application
PNG	Portable Network Graphics
QMS	Quality Management System
QSR	Quality System Regulations
R&D	Research and Development
RAID	Redundant Arrays of Inexpensive Disks,
ROI	Return on Investment
RUO	Research Use Only
SE	Substantially Equivalent
SNDA	Supplemental New Drug Application
SPL	Structured Product Labeling
STED	Summary Technical Documentation
SVG	Scalable Vector Graphics
TB	Terabyte
TIG	Telematics Implementation Group
XML	Extensible Markup Language
XSL	Style Sheets