Laws, Regulations, Guidance, and Concept Papers
- FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and have been promised by FDA.
- Another 2 guidance were also published this week.
- No guidance was published by the EMA.
- WHO published 1 document.
- The non-guidance collection included the usual sets from MHRA, EMA, FDA, and associated bodies.
- Among the more interesting is the MHRA publication of issues commonly identified in clinical trial applications, and part II in one of the inspectorate blog entries.
This week in our GMP Regulatory Newsletter, we published a brief supplement addressing warning letter enforcement actions taken in the first half of 2018. We will update this information, as we’ve done in the past few years, in a larger report at the end of the FDA fiscal year – start your FREE GMP Regulatory Intelligence Trial today.
- FDA published only 1 warning letter this week to an API firm in China.
- OPDP published their 3rd untitled letter this year.
- To be noted are 2 483s to compounding firms and 2 483s to pharma firms including a Hospira site in India (another 32-page 483).
- A variety of recalls and 2 safety alerts.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at [email protected].
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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