Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

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

  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 
  41. 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.
  42. 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