Regulated Product Submissions

Results: 33



#Item
1

Regulated Product Submissions (RPS) Nancy Shadeed DITTA Workshop on RPS March 23, 2015

Add to Reading List

Source URL: globalditta.org

- Date: 2015-03-26 04:21:20
    2Technology / Drug safety / Regulated Product Submissions / Aviator / Global Harmonization Task Force / Food and Drug Administration / IVD / Medical device / Medicine / Medical equipment / Health

    IMDRF Table of Contents (ToC) Pilot Plan

    Add to Reading List

    Source URL: www.imdrf.org

    Language: English - Date: 2015-04-06 23:45:16
    3Grants / Research / Pharmaceutical sciences / Medicine / Drug safety / Regulated Product Submissions / Global Harmonization Task Force / Specification / Electronic submission / Technology / Competitions / Digital media

    IMDRF/RPS WG/N26FINAL:2015

    Add to Reading List

    Source URL: www.imdrf.org

    Language: English - Date: 2015-04-06 23:45:17
    4Folder / Regulated Product Submissions / Computer file / Portable Document Format / Computing / Computer file formats / ISO standards

    Proposed document: Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (ToC-based submissions)

    Add to Reading List

    Source URL: www.imdrf.org

    Language: English - Date: 2015-04-09 21:29:28
    5Pharmaceutical sciences / Food and Drug Administration / Abbreviated New Drug Application / Unique Ingredient Identifier / Regulated Product Submissions / Structured Product Labeling / Medicine / Health

    How FDA validates reported suspect products in adverse event reports submitted to FAERS

    Add to Reading List

    Source URL: www.fda.gov

    Language: English
    6Health informatics / Health Level 7 / Regulated Product Submissions / Medical informatics / Health / Medicine

    Presentation: RPS Work Item: Beta Testing of Message Standard

    Add to Reading List

    Source URL: www.imdrf.org

    Language: English - Date: 2014-08-28 20:12:39
    7Pharmaceutical sciences / Medicine / Prescription Drug User Fee Act / Electronic Common Technical Document / Regulated Product Submissions / Food and Drug Administration / Pharmaceuticals policy / Health

    PDUFA IV IT PLAN ABBREVIATED UPDATE MAY 2010

    Add to Reading List

    Source URL: www.fda.gov

    Language: English
    8Health / Clinical research / Pharmaceuticals policy / Prescription Drug User Fee Act / Medical informatics / Drug safety / Regulated Product Submissions / Center for Biologics Evaluation and Research / Adverse Event Reporting System / Food and Drug Administration / Medicine / Research

    Microsoft Word - PDUFA IV Annual IT Assessment _FY2010_.doc

    Add to Reading List

    Source URL: www.fda.gov

    Language: English
    9Clinical research / Pharmaceuticals policy / Pharmaceutical industry / Medical informatics / Food and Drug Administration / United States Public Health Service / Regulated Product Submissions / Validation / Regulatory requirement / Pharmaceutical sciences / Research / Medicine

    Microsoft Word - CESG Reformat.DOC

    Add to Reading List

    Source URL: www.trade.gov

    Language: English - Date: 2012-05-15 10:51:48
    10Medicine / Clinical research / Pharmaceutical industry / Food and Drug Administration / Medical equipment / Clinical trial / Regulated Product Submissions / Specification / Medical device / Technology / Technical communication / Science

    IMDRF /RPS WG/N13FINAL:[removed]te~national Medical Regulators Forum .IMDRF lnDeviCe .

    Add to Reading List

    Source URL: www.imdrf.org

    Language: English - Date: 2014-08-13 01:12:35
    UPDATE