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  • 1.  Periodic Benefit Risk Evaluation Reports (PBRER)

    Posted 01-Nov-2012 18:33

    The EU will require the Periodic Benefit Risk Evaluation Reports (PBRER) format starting on January 10, 2013 and companies are interested in submitting the PBRER for harmonization purposes.

    I would be interested to hear if anyone has attempted to submit a PBRER to FDA in place of a Periodic Safety Update Reports (PSUR)?  If so, was it accepted by FDA and what mechanism did you use to get FDA to agree to accept it?

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    Irene Schubert
    Director
    Novo Nordisk, Inc.
    Princeton NJ
    United States
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  • 2.  RE:Periodic Benefit Risk Evaluation Reports (PBRER)

    Posted 03-Nov-2012 17:01
    Dear Irene,

    I am in the process of filing waivers for PBRERs in lieu of PADERs.  Under §314.90(a)(2), you can file another report to satisfy post-marketing requirements.  I think the FDA will be lenient on accepting PBRERs as they have a previous track record of accepting PSURs in lieu of PADERs.  You may need to file a bridging report to the FDA if your anniversary date is different from the EU anniversary date once you receive acceptance for your waiver.


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    Gregory Ringenberg, Pharm.D., M.S., R.Ph.
    Post-Doctoral Fellow
    Bayer HealthCare
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    Original Message


  • 3.  RE:Periodic Benefit Risk Evaluation Reports (PBRER)

    Posted 05-Nov-2012 03:46

    Hi Irene,

    PBRER is all EU specific and nothing to do with FDA. Its just a new format of PSUR that includes the benefit and risk evaluation of the products concerned and should be submitted yearly to the EU according to the periodicity of the PSUR.

    FDA requires Development Safety update report (DSUR) in place of PSUR since 2012. Also sponsors are in the process of harmonising the DSUR section with the Annual Report sections. Also please refer to the Guidance for Industry, "E2F Development Safety Update Report," dated August 2011, as well as the introductory statement, "US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and can therefore take the place of these existing reports."Hope this helps.

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    Venkatesh Rao
    Novartis HCPL, Hyderabad
    India
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    Original Message