Rx REPORT

CBER Publishes their Updated 2017 Guidance Agenda

12 July 2017
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Summary

FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

11 April 2017
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Summary

EMA Implementation Strategy of ICH Q3D Guideline

10 April 2017
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Summary

EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents

7 April 2017
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Summary

Agreement on Mutual Recognition Between EU Community and US FDA

6 April 2017
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Summary

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products

6 April 2017
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Rx REPORT

Monitoring and Reporting Working Group Posts New Resources

10 March 2017
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Document

FDA Office of Generic Drugs Issues 2016 Annual Report

10 March 2017
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Document

CDER Issues Updated CY2017 Guidance Agenda

10 March 2017
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Summary

FDA Medical Device Inspection Observation Summary Published

10 March 2017
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