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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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.
Both federal agencies extended grants to help investigators adapt to the changes mandated by the COVID-19 pandemic.