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U.S. Department of Health and Human Services

For Industry

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Under what circumstances is it appropriate to use secure e-mail between FDA and a manufacturer when there is a question involving the manufacturer’s product?

CBER has provided guidance on electronic communication since 1999, when it issued its Guidance for Industry Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format — Biologics Marketing Applications intended to assist applicants in making regulatory submissions in electronic format. The guidance indicated that it was the first in a series of guidance documents on electronic submissions that would be updated periodically to reflect evolving technology and experience in using this technology. Following this guidance, CBER issued the following guidance over the next several years:

  • Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs), issued March, 2002;
  • Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application, issued August, 2003;
  • Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General Considerations, issued October, 2003;
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Content of Labeling, issued April, 2005;
  • Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Receipt Date, issued June, 2007;
  • Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format – Lot Release Protocols, issued November, 2007;
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format— Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, issued June, 2008;
  • Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports, issued June, 2008;
  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing, issued May, 2009

Questions about implementation of the above guidance documents or any CBER issued guidance documents should be addressed to Industry.Biologics@fda.gov. All of the above guidance documents along with other guidance documents concerning submissions to FDA can be found on the web. Additional information may also be found in CBER’s Standard Operating Procedure and Policy (SOPP) 8119: Use of Email for Regulatory Communications.

 

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