Need For Advanced Manufacturing Technologies A ‘Great Learning’ From The Pandemic, CBER’s Marks Says
COVID-19 highlighted limited domestic capacity and need for more flexibility, agility and reliability in manufacturing processes, says FDA biologics center director Peter Marks; he also discussed differences in data review for vaccine BLAs relative to EUAs.
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CRS poses series of questions about how a new federal agency tasked with speeding translational research for treating high-impact diseases would work, including potential downsides and whether it would duplicate government programs already in place.
Reps. Diana DeGette and Fred Upton are looking to President Biden and his new plan for a translation health research group at NIH to get their next itineration of 21st Century Cures across the finish line. A discussion draft is expected in early June.
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.