COVID-19 Prompts WHO To Propose Revisions To GMPs For Investigational Drugs Guideline
WHO Also Proposes GMPs For R&D Facilities
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.
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Agency describes criteria for waiving routine prequalification inspections for existing drugs and vaccines as well as new products in light of COVID-19.
The US FDA tells manufacturers in two recent warning letters to get to the root cause of contamination problems and take a more proactive approach to cleaning and equipment maintenance.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.