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鶹ֱ & Lardner LLP attorneys David Rosen and William Holtz are quoted in the PharmaVoice article, “,” examining the FDA’s accelerated drug approval initiatives and its impact on smaller pharmaceutical companies.
“There is some talk about perhaps putting some of these things into the next prescription drug user feed amendments, which is being negotiated right now,” said Holtz.
Rosen emphasized the intensified challenges for smaller companies, noting, “There’s pressure to do it better, quicker, sooner, faster to get their studies done, to try to utilize surrogate markers, for example, to not have to wait for certain other efficacy outcome variables to be done.”
This speed can result in financial risks, as “if they have to run a second trial it makes it much more difficult to raise money,” he continued.
