FDA Seeks Comments on New International Conference Draft PBRER
The Food and Drug Administration announced the availability of a draft guidance for industry entitled "E2C(R2) Periodic Benefit-Risk Evaluation Report," prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
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The draft updates and combines two ICH guidances, "E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs" and "Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs." The draft describes the format, content, and timing of a periodic benefit-risk evaluation report (PBRER) for an approved drug or biologic.
The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions (European Union, Japan and the U.S.) and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities, FDA said in a Federal Register notice.
Comments on the draft are due by May 11, 2012, to http://www.regulations.gov, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Further Information: Andrea Feight, 301-796-0152.