PDUFA reauthorization: AstraZeneca offers detailed recommendations
Although the performance and procedural goals for the sixth iteration of the US Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022.
Zachary Brennan, writing originally for the Regulatory Affairs Professionals Society (RAPS), the global organization for those involved with the regulation of healthcare and related products, examines the issue.
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