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Stability testing and control

This article was originally published in The Tan Sheet

Executive Summary

Workshops addressing avoidance of stability issues in the development of drug products, sponsored by CHPA, FDA, USP and other bodies, will be held in New Jersey June 28, Puerto Rico July 19, Missouri Aug. 2 and California Aug. 16. Objectives for the workshops include a review of the FDA draft guidance on stability released in June 1998, methods for establishing expiration dates and ensuring methods are stability indicating

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Stability Data Reporting Section In FDA Draft Report Will Be Amended

FDA will change the stability data reporting section of its June 1998 draft stability guidance to address comments to the agency following the draft's release, Center for Drug Evaluation & Research Stability Coordinating Committee Chairman Robert Seevers, PhD, said at an industry/FDA "Stability Testing and Control" meeting in East Rutherford, N.J. June 28.

Stability Data Reporting Section In FDA Draft Report Will Be Amended

FDA will change the stability data reporting section of its June 1998 draft stability guidance to address comments to the agency following the draft's release, Center for Drug Evaluation & Research Stability Coordinating Committee Chairman Robert Seevers, PhD, said at an industry/FDA "Stability Testing and Control" meeting in East Rutherford, N.J. June 28.

Stability Data Reporting Section In FDA Draft Report Will Be Amended

FDA will change the stability data reporting section of its June 1998 draft stability guidance to address comments to the agency following the draft's release, Center for Drug Evaluation & Research Stability Coordinating Committee Chairman Robert Seevers, PhD, said at an industry/FDA "Stability Testing and Control" meeting in East Rutherford, N.J. June 28.

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