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U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics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 Provides Notice to Public of Website Location of CDRH FY 2018 Proposed Guidance Development

4 January 2018
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Rx REPORT

U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles

4 January 2018
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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FDA Issues Draft Guidance on Refuse-to-Receive Standards: Questions and Answers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FDA Issues Draft Guidance on ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA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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Rx ALERT

Request for Information – Disaster Impact Assessment in Puerto Rico and Other Locations

29 September 2017
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