COVID-19 Prompts WHO To Waive Onsite Prequalification Inspections
Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.
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Accelerated development of COVID-19 products prompts World Health Organization to revise a guideline on good manufacturing practices for investigational drugs and propose a new guideline applying GMP principles to R&D facilities.
Phased approach will prioritize the safety of FDA and industry employees while striking ‘an appropriate balance between a scaled-back surveillance inspection program and the continuation of providing robust regulatory oversight,’ Commissioner Hahn says in a memo from self-isolation.
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.