Summary

FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

16 February 2018
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Rx REPORT

CDER Issues Planned Guidance Agenda for CY2018

22 January 2018
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Rx REPORT

U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics

5 January 2018
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Rx REPORT

FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers

28 November 2017
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Rx REPORT

FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA

28 November 2017
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Summary

Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

14 November 2017
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Summary

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.

11 September 2017
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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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