August 20, 2019 | FDA to Close Public Consultation on ICH M10 Bioanalytical Method Validation
The US Food and Drug Administration (FDA) public consultation of the International Council for Harmonisation (ICH) draft guideline, M10 Bioanalytical…Read More
April 16, 2019 | Kneat Launches Annual ‘Customer Summit’ to Enable Customer-Driven Development
HALIFAX, April 16, 2019/– Kneat is pleased to announce the launch of the inaugural Kneat Customer Summit, the first in…Read More
February 28, 2019 | FDA’s New Continuous Manufacturing Guidance Carries Process Validation Implications
In a new 27-page Guidance, ‘Quality Considerations for Continuous Manufacturing’, released February 27, 2019, the FDA and CDER (Center for…Read More
January 24, 2019 | FDA Release New Method Validation Guidance
Finalizing a draft guidance first issued in April 2016, the FDA have this week released a new final guidance for…Read More
December 20, 2018 | FDA Release New Data Integrity Guidance
Data Integrity remains a key focus for the FDA in 2018, now five years on since the subject was first…Read More
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