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.
You may also be interested in...
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.
EU authorities say the new tools and concepts needed for implementing the new international guideline on post-approval changes (ICH Q12) will be considered when the EU framework is reviewed.
Upcoming ICH Q12 implementation guidance will translate terminology on post-approval changes into a US context, said a US FDA official who also shared some lessons learned on established conditions.