Rx ALERT

FDA Orders Recall of Salmonella-Tainted Kratom Products Nationwide

4 April 2018
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Summary

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

19 March 2018
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Rx REPORT

FDA Office of Pharmaceutical Quality Issues Their Annual Report

8 March 2018
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Summary

FDA Unique Device Identification: Direct Marking of Devices

5 March 2018
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Summary

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

16 February 2018
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Rx ALERT

Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin Shortage

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U.S. FDA Issues Draft Guidance on CMC Changes to an Approved Application for Certain Biologics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U.S. FDA Issues Draft Guidance on The Least Burdensome Provisions: Concepts and Principles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