Rx REPORT

FDA Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

22 June 2018
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Rx REPORT

FDA Office of Pharmaceutical Quality Issues Their Annual Report

8 March 2018
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Rx REPORT

WHO Issues Report on Global Surveillance and Monitoring System for Substandard and Falsified Medical Products

16 February 2018
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Rx REPORT

Work Plan for the Biologics Working Party (BWP) for 2018

13 February 2018
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Rx REPORT

Work plan for the joint CHMP/CVMP Quality Working Party (QMP) for 2018

13 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U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics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 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U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles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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