Rx REPORT

U.S. Announced Proposed Program – Voluntary Malfunction Summary Reporting Program for Manufacturers

4 January 2018
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Rx REPORT

U.S. FDA Announces Pilot Program – Fostering Medical Innovation: Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot

4 January 2018
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Rx REPORT

U.S. FDA Issues Revised MAPP on Naming of Drug Products Containing Salt Drug Substances

27 December 2017
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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FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers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FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA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

FDA Announces Pilot Project Program Under the Supply Chain Security Act

3 August 2017
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Summary

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

3 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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