Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.
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The disclosure requirement to participate includes an option for the US FDA to include the ideas on new regulatory uses for real-world evidence in a guidance or speak about them at public forums in order to ‘promote innovation.’
Study showed osteoarthritis patients are more willing to accept risk of joint damage with NGF-inhibitors than dependency associated with opioids, Pfizer said; however, FDA highlighted key flaws in study design, sample population and survey content.
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.