US FDA To Train Investigators On mRNA Vaccine Manufacturing
Agency seeks bids to train biologics field personnel on relevant aspects of mRNA technology such as corralling stray plasmids or nanoparticles as the possibilities for the technology expand in the wake of the Pfizer/BioNTech and Moderna COVID-19 vaccine successes. Review documents suggest the first mRNA vaccine inspections focused on more traditional issues.
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Agency is hiring contractor to identify gaps in the ability of inspectors, investigators and compliance officers to oversee manufacturing quality in the context of new and emerging technologies – and to identify organizations that could fill the gaps through training.
$10bn here and $6bn there on top of what’s left from earlier CARES Act gives government more options on COVID-19 medical countermeasures.
ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.