Here is your PDF: Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments; Keywords: guidance specifications electronic technical ng postmarketing safety

The number of pages within the document is: 23

The self-declared author(s) is/are:
FDA/CDER

The subject is as follows:
Original authors did not specify.

The original URL is: LINK

The access date was:
2019-02-09 19:01:07.505802

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The content is as follows:
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments Technical Specifications Document Associated Guidance Documents: Dra ft Guidance for Indus try: Providi ng Submissions in Electronic Format ΠPostmarketing Safety Reports (June 2014) Draft Guidance for Industry: Postmarketing Safety Reporting for Combination Products (February 2018) For questions regardi ng this technical specific ations docu ment, contact (CDER) Suranjan De at 240-402-0498, or (CBER) Office of Commun ication, Out reach and Develop ment at 301 -827-1800 or 800-835-4709. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research ( CDER) Center for Biologics Evaluation and Research (CBER) February 2018

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