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Home » Topics » Regulatory » PDUFA

PDUFA
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Calendar pages

Still on deck for FDA action, developers continue to wait beyond PDUFAs

Feb. 2, 2021
By Karen Carey
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
Read More
Calendar pages

Still on deck for FDA action, developers continue to wait beyond PDUFAs

Feb. 2, 2021
By Karen Carey
While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
Read More
Meeting illustration

Tsunami of change to challenge PDUFA VII

July 23, 2020
By Mari Serebrov
Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies looking to be prominent features of the next five-year user fee agreement. Politics likely will play a role as well.
Read More

PDUFA, BsUFA delays could be in the offing

May 27, 2020
By Mari Serebrov
As the FDA continues to shift its limited resources to the development and review of COVID-19 therapies and vaccines, other drugs in the pipeline may be delayed. In a question-and-answer guidance released late Tuesday, the agency acknowledged that, going forward, it may not be able to sustain its current performance level in meeting all its goal dates for new drugs and biologics.
Read More
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