Electronic Regulatory Review

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

• Electronic Document Room (EDR)
• Secure Electronic Mail and the FDA Electronic Submissions Gateway
• Division Files System (DFS)
• Reviewer Training

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 the Electronic Submissions Gateway page.
• For more information on establishing a Secure Electronic mail link with CDER, contact Wendy Lee at: wendy.lee@fda.hhs.gov

Division Files System (DFS)

• 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.
  
  

Reviewer Training

• 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.