Partner Maarika Kimbrell is featured in a Pink Sheet analysis about the effects of the Food and Drug Omnibus Reform Act (FDORA), which gave the US Food and Drug Administration (FDA) authority to require that confirmatory trials be underway at the time of accelerated approval. Maarika noted that prior to the passage of FDORA, the agency had already begun prioritizing the quick commencement and completion of trials.
“So the new authority, I think, dovetails with that,” said Maarika. “I do think we've seen over the course of the last year industry begin to respond to that and have plans underway perhaps earlier than before [and] really having that as more of the forefront of discussions when it comes to figuring out accelerated approval pathways.”
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