Rx REPORT

FDA Announces Pilot Project Program Under the Supply Chain Security Act

3 August 2017
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FDA – Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA)

3 August 2017
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Summary

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

1 August 2017
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Summary

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices

1 August 2017
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Rx REPORT

FDA Announces Exemptions from Premarket Notification for Class II Devices

12 July 2017
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Rx REPORT

New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017

10 May 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

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

6 April 2017
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Rx ALERT

Second Chinese company found shipping APIs from a banned manufacturer

17 March 2017
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Document

FDA Office of Generic Drugs Issues 2016 Annual Report

10 March 2017
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