US FDA's Surveillance Office Using Predictive Analytics To Measure Pharmaceutical Quality
Executive Summary
The US FDA used predictive analytics to mine data from 346 field alert reports to gauge the strength of manufacturers’ quality systems with the idea of using it to help set inspection priorities.
You may also be interested in...
FDA Relying More On Predictive Analytics To Help Monitor Quality Risks Of Sites During Pandemic
Analytics tool plays key role in helping agency oversee quality of 1,800 newly registered hand sanitizer facilities despite travel restrictions.
FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments
FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.
FDA Resumes Quality Metrics Effort With Feedback And Site Visit Initiatives
FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.