Laws, Regulations, Guidance, and Concept Papers
We have another slow week in the publication of guidance:
- FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding
- EMA published 1 item addressing pharmacogenomic practices
- CDSCO (India) and TGA each published 1
We see the usual collection of non-guidance items from MHRA, EMA, FDA, and HPRA this week. This includes 2 ‘work plan’ items from the EMA.
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This week of interest are:
- 1 device warning letter
- 3 warning letters to drug manufacturers
Each of the 3 drug warning letters includes a list of additional information that the firm is to provide to FDA in response to the letter. We also see Class I, II, and III drug recalls this week. In the device area, it seems that the falsely low results in in-vitro testing for blood levels of lead has been resolved. The culprit is a component in some rubber stoppers in BD Vacutainers® that are now the subject of a Class I recall.
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About the Author
Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.
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