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Electronic Regulatory Submissions and Review
Welcome to the Center for Drug Evaluation and Research's Electronic Regulatory Submissions and Review (ERSR) web page. This page provides information about the electronic submission of regulatory information to
the Center and the review of it by CDER staff. Additional guidance documents, when available in draft or final form, will be added to this page.
NOTICE: Click here for important instructions regarding electronic submissions, effective January 1, 2008.
Submission of Electronic Documents (6/7/2004)
- Send all electronic submissions (except ANDAs) to:
5901-B Ammendale Road
Beltsville, MD 20705
- Send ANDA submissions to:
7500 Standish Place, E-150
Rockville, MD 20855
- CDER and the Center for
Biologics Evaluation and Research (CBER), has co-published a guidance document called Guidance for Industry: Providing
Regulatory Submissions in Electronic Format - General Considerations.
 This document provides general
information about the electronic submissions process.
- Note: In the general considerations guidance, we recommend the following:
Digital Tape - Digital Equipment Corp. DLT 20/40 and 10/20 GB format using OPENVMS with VMS backup or NT server 4.0 with NT backup or backup exec."
Since the release of this guidance, there
have been some changes in CDER. First, we are currently not able to accept tapes using
OPENVMS with VMS backup. Second, we are able to use 35/70 DLT tapes. We are not, however,
able to handle 40/80 DLT tapes. We are working on an update to this guidance and plan to
add this information accordingly. (Posted 3/1/2001)
Since the above posting on
March 1, 2001, CDER is now able to handle 40/80 DLT tapes though we prefer
35/70. CDER cannot process DLT tapes that have been prepared using the
backup applet included with the Windows 2000 operating system. It is
recommended that systems running Windows 2000 use backup exec to produce
the DLT transport tape for CDER. (Posted 9/28/01).
Abbreviated New Drug Applications (ANDAs)
- Information on electronic datasets that accompany an ANDA submission:
You may now submit ANDAs in electronic format in place of paper. We have placed the ANDA on public docket 92S-0251 as a submission acceptable in electronic format as allowed under 21 CFR Part 11. It should be noted that Part 11 requires that datasets provided in electronic format and used in the review process meet the requirements for archiving, i.e., protection of those records to enable their accurate and ready retrieval throughout the records retention period.
Electronic datasets, including those accompanying a paper submission cannot be considered as official and used to support the application if they are submitted in a file format that is not archivable. As FDA and industry progress in meeting the goals of use of electronic submissions, compliance with electronic submission regulations will be expected. Typically, electronic datasets accompany an ANDA application to support the review of bioequivalence studies. With the implementation of the guidance for industry Providing Regulatory Submissions in Electronic Format – ANDAs (June 2002), the submission of these dataset records for use in the review should be in archivable format. At this time, the archival dataset format is SAS Transport. (Posted 7/15/2002)
- Guidance for Industry: Providing
Regulatory Submissions in Electronic Format - General Considerations.
Annual Reports for New Drug Applications (NDAs)
- Please refer to: Providing Regulatory Submissions in
Electronic Format - Human Pharmaceutical Product Applications and Related
Submissions [HTML]
or [PDF].
Carcinogenicity Data
- An example of
a SAS transport file for carcinogenicity data set is available. This is a
self-extracting ZIP file that will be loaded to your C drive. If you download this
file, the path to the example is: C:\WINDOWS\TEMP\example\N123456\pharmtox\datasets\101.
For more information on carcinogenicity data, please contact Karl
Lin at karl.lin@fda.hhs.gov.
Providing Digital Electrocardiogram (ECG) Data
Why:
FDA is interested in having access to ECG waveform data collected during the course of "definitive" studies on drug effects on ventricular repolarization and annotated for interval measurements. The basis for this interest is described in detail in the concept paper, "The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs," jointly authored by the U.S. and Canadian regulatory authorities and discussed at a joint FDA/DIA meeting in January 2003.
How:
In 2004, FDA announced its intent to accept annotated ECG waveform data in electronic format (XML) following the Health Level Seven (HL7) Annotated ECG Waveform Data Standard (aECG) accredited by the American National Standards Institute. You can find more detailed information on the aECG message standard and supporting materials
by visiting the HL7 Version 3 ECG page and following the "Link to ECG Annotation Message Review Material." To facilitate access to the aECG data, FDA has entered into a Cooperative Research and Development Agreement (CRADA) with Mortara Instruments to develop and implement a digital data warehouse to collect, store, and archive aECG data from controlled clinical trials. FDA reviewers have access to this data warehouse to support their assessment of the risk of new drugs.
You can upload data to the warehouse for FDA access at the Mortara ECG Warehouse. For questions, contact the project manager in the appropriate review division.
Drug Master File (DMF)
- Refer to the Guidance for Industry: "Providing Regulatory Submissions
in Electronic Format — Human Pharmaceutical Product Applications and
Related Submissions Using the eCTD Specifications" [HTML]
or [PDF] for information on the submission of electronic DMFs.
- For more information on electronic submissions for DMF, please contact CDER at esub@fda.hhs.gov. General DMF questions may be sent to dmfquestion@cder.fda.gov.
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Investigational New Drug Applications (INDs)
- On March 26, 2002, FDA published final guidance on the submission of INDs in electronic format to the Center
for Biologics Evaluation and Research (CBER) (http://www.fda.gov/cber/gdlns/eind.pdf)
. Once the IND submission to CBER is posted on public docket 92S-0251, we will be capable of accepting INDs submitted to CBER in electronic format without paper copies. At this time, we are not extending this to INDs submitted to CDER.
The electronic IND guidance leverages the
current BLA/NDA guidances and the experience set from CBER's eIND
pilot program. This guidance features PDF tables of contents, roadmap
files, and a folder structure that enables the reviewer to easily access
and review documents. We expect the experience of receiving the IND
applications and amendments with or without media, featuring an
electronic signature, as well as the review of these electronic INDs
submissions to help the FDA further other electronic submission
initiatives.
In the future, we plan on upgrading the
electronic IND filing and review process to include the use of XML-based
technology. We are currently working toward accepting the electronic
common technical document using XML for marketing applications and will
build on this to accept XML-based electronic INDs. Once this is
completed, we will then issue draft guidance that incorporates the XML-based
technology for all INDs including those submitted to CDER. We hope to
have XML specifications for electronic INDs available in 2003.
Launch Material and Other Submissions to the Division of Drug Marketing, Advertising, and Communications (DDMAC)
New Drug Applications (NDAs)
Voluntary Electronic Submissions
- Postmarketing
Expedited and Periodic ICSRs
Memoranda to Docket 92S-0251 that allows for voluntary electronic submission of all postmarketing individual case safety reports, whether expedited or periodic, in electronic format in place of paper.
- Descriptive Information of Periodic Reports Memorandum to Docket 92S-0251 that allows for voluntary electronic submission of the descriptive information of postmarketing periodic adverse experience reports in electronic format in place of paper.
Guidances
Specifications
Submit comments and queries on these specifications to the AERS Electronic Submission Coordinator at aersesub@fda.hhs.gov.
Related Information
- Adverse Event Reporting System (AERS). A program permitting electronic submission of individual case safety reports by applicants, manufacturers, packers, and distributors for marketed drug and biological products, including therapeutic vaccines, but excluding prophylactic vaccines, whole blood and components of whole blood. The electronic submission format follows the International Conference on Harmonization (ICH) standards. For more information on the ICH, please contact Gary Gensinger at gary.gensinger@fda.hhs.gov.
- For information on FDA’s intention to require electronic submission of postmarketing safety reports, see 63 FR 59746, Advanced Notice of Proposed Rulemaking (ANPRM) for Electronic Reporting of Postmarketing Adverse Drug Reactions, published on November 5, 1998.
Related Web Sites
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Electronic Document Room (EDR)
- The EDR is an extension of the central document room. We perform a check on each submission sent to the EDR for file formats used and integrity of bookmarks and hypertext links.
- NDA Conformance Check List
(2/22/2000)
Secure Electronic Mail and the FDA Electronic
Submissions Gateway
- Electronic mail is in widespread use within CDER and industry. Secure
email between CDER and industry is useful for informal communications when
confidential information maybe included in the message (for example trade
secrets or patient information). Secure email should not be used for
formal regulatory submissions (for example NDAs, INDs, amendments and
supplements).
- Formal regulatory submissions can be securely submitted to CDER via
the FDA Electronic Submissions Gateway (ESG). For more information on the
FDA ESG see:
http://www.fda.gov/esg/default.htm
- For more information on establishing a Secure Electronic mail link
with CDER, contact Wendy Lee at:
wendy.lee@ fda.hhs.gov
- DFS is the cornerstone of the Administrative
Management of Files (AMF) initiative. It provides document management, tracking,
archiving, and electronic signature capabilities for internally generated review
documents. It also provides search and retrieval capabilities for final versions of
internally generated review documents.
- DFS is being developed incrementally. The
first phase focuses on building an electronic repository for final review documents and
for capturing signature information. The review documents tracked and saved by
DFS are associated with regulatory submissions in the Centerwide Oracle Management
Information System (COMIS). Future phases of DFS will include an update of COMIS
assignments when the author signs the review in DFS. Reviewers use DFS to check in
final review documents, to route them for sign off, to sign off on them electronically, to
automatically store review documents in the electronic repository, and to find and view
documents stored in the DFS electronic repository.
- The DFS is a graphical user interface (GUI)
software application that has the look and feel of most Windows-based applications.
DFS uses standard Windows features, such as icons, drop-down menus, buttons, scroll bars,
and dialog boxes.
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- Electronic Submissions Training (EST).
Instructs reviewers on how to search for a specific NDA via the Electronic Document Room (EDR) Intranet site
and to map the drive path of the folder. Acrobat Exchange is then used to open,
navigate, view, follow links, create electronic notes, and copy and paste text, tables,
and graphics into other applications from a sample electronic NDA.
- Electronic Data Analysis Training (EDAT).
Instructs reviewers on how to access NDA data in SAS Transport format via
the Electronic Document Room (EDR) and to convert the files to formats that can be used
with a variety of software packages. NEDAT incorporates the use of the SAS System
Viewer, Stat/Transfer, and JMP to convert the data and perform basic analysis.
Additional introduction to JMP courses are also available that discuss analysis of adverse
events, exposure, efficacy, lab, and demographic data.
- Creating Portable Document Format Reviewer Documents.
Instructs reviewers on how to create a Portable Document Format (PDF)
version of a review document that maintains the formatting of the original MS Word
document. Instruction covers fonts, paragraph, page, and section formatting needed prior
to converting an MS Word review document to the PDF archiving standard used in the
Division Files System (DFS). Adobe Acrobat 4.0 is then used to convert the document
to PDF and to open, view, and enhance the PDF review document.
- JMP. An introduction to JMP teaches
reviewers how to use JMP to review electronic data. Users learn how to use a variety
of JMP functions to analyze electronic data, with a specific focus on adverse event,
laboratory, exposure, and efficacy data. Basic functions of summary tables, graphs,
statistical tests, and the formula calculator are covered. The course is taught in
the computer lab with hands-on instruction. Prior completion of the NDA
Electronic Data Analysis Training
(NEDAT) course and/or familiarity with electronic datasets is recommended. Although
primarily geared toward the clinical reviewer, the course provides useful instruction for
reviewers of all disciplines.
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- PDF is an open format developed by Adobe Systems. Additional information is available at http://www.adobe.com.
- For more general information regarding the preparation of submissions in electronic format, please contact the Electronic Submissions Coordinator at esub@fda.hhs.gov.
- GPHA Technical Conference, October 2008, Rockville, MD
- Virginia Ventura, Team Leader, eSubmission Support, Office of Business Process Support, CDER
Creating a Reviewable ANDA in eCTD Format [PDF]
- Connie Robinson-Kuiperi, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER, Electronic ANDA Top 10 Issues [PDF]
- Donovan Duggan, Regulatory Information Specialist, eSubmission Support, Office of Business Process Support, CDER, Gateway Submissions and eCTD Validation [PDF]
- DIA eCTD Conference, November 2008, San Diego, CA
- Robinson-Kuiperi, Connie, Regulatory Information Specialist, Office of Business Process Support, CDER:
- Duggan, Donovan, MBA, Regulatory Information Specialist, Office of Business Process Support, CDER, Implications of eCTD errors [PDF]
- Robinson-Kuiperi, Connie AND Duggan, Donovan, MBA, Regulatory Informations Specialists, Office of Business Process Support, CDER:
- DIA Electronic Document Management Meeting, February 7, 2008, Philadelphia, PA
- Chazin, Howard, M.D., MBA, Acting Associate Director for Safety, Office of New Drugs, CDER, Safety Review in the eCTD [PDF]
- Duggan, Donovan, MBA, Regulatory Information Specialist, Office of Business Process Support, CDER, eCTD Validation [PDF]
- Fauntleroy, Michael, Program Manager, FDA Electronic Secure Gateway Project, CBER, Electronic Secure Gateway Update [PDF]
- Furlong, Lesley-Ann, M.D., Clinical Reviewer, CDER, Clinical Reviewer's Perspective on Working with Data [PDF]
- Gensinger, Gary, MBA, Director, Regulatory Review Support Staff, Office of Business Process Support, CDER:
- Pope, Sarah, Ph.D., Chemist, Pharmaceutical Assessment Lead, Office of Pharmaceutical Science, CDER, Chemistry Reviewer's Perspective on the eCTD [PDF]
- Ventura, Virginia, Regulatory Information Specialist, Office of Business Process Support, CDER, eCTD Waivers [PDF]
- 42nd Annual Meeting of the Drug Information Association, June 18-22,
2006, Philadelphia, PA
- Gensinger, Gary, MBA, Director, Regulatory Review Support Staff, Office
of Business Process Support; Standards and Successful Document Creation
[PPT] [PDF]
- Ventura, Virginia, Regulatory Information Specialist, FDA Office of
Business Process Support; eSUBS and eCTDs: Practical Advice and
Pitfalls to Avoid [PPT]
[PDF]
- Electronic Common Technical Document (eCTD) Tutorial, 4/22/2005, Rockville, MD
Agenda and Presentations(4/26/2005)
- Electronic Submissions and Data Standards Quarterly Update, 3/4/2004, Rockville, MD, FDA
- Update on SEND (Standard for Exchange of Nonclinical Data), Thomas Papoian, Ph.D., CDER [HTML] or [PPT]
- Overview of the eCTD Guidance and Its Implementation, Gary M. Gensinger, MBA, CDER [HTML] or [PPT]
- Introduction to SDTM v3.1, Norman Stockbridge, CDER [HTML] or [PPT]
- Study Tagging File Workshop [PPT slides] Thomas Selnekovic, CDER, 2/26/2004
- eCTD Workshop, February 26, 2004, Randy Levin, MD. CDER [HTML] or [PPT]
- Public Meeting on Clinical Data Interchange Standard Consortium (CDISC) Version 3 Submission Data Standards and Electronic Case Report Tabulations, October 2, 2003, Rockville, Maryland.(Posted 10/7/2003)
- 2003 Annual DIA Meeting, June 2003, San Antonio TX (Posted 7/15/2003)
- DIA Annual Clinical Data Management Meeting in Philadelphia held on March 31, 2003.
- DIA Electronic Document Management Meeting, February 13, 2003.(Posted 2/24/2003)
- Electronic Submissions to the FDA, Randy Levin, MD, 5th Annual Electronic Document Management Conference, 9/23/2002. (Posted 11/14/2002)
- Impact of Regulations on Data Management Practice, Randy Levin, MD, DIA 12th Annual European Clinical Data Management Conference, 11/5/2002. (Posted 11/14/2002)
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Date created: November 24, 1999; updated December 10, 2008 |
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