US FDA Complete Response Letter Rates Vary With Sponsor Size
Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.
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Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.
Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.