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Bio/Pharma Impacts of the FDA Commissioner's National Priority Voucher (CNPV) Program
1.
How significantly will CNPV influence your organization's planning for regulatory submission strategies, aiming for the accelerated 1–2 month review?
Very Significantly (A major shift in R&D and manufacturing planning)
Significantly (Will prioritize qualifying products)
Moderately (Minor adjustments, but not a primary driver)
Minimally (Little to no impact)
Not Applicable / Unsure
2.
How likely is your organization to invest in new US facility capacity specifically to increase the chances of qualifying for accelerated FDA review?
Very likely
Somewhat likely
Neutral/Depends on the market
Somewhat unlikely
Very unlikely
3.
How transparent and predictable do you find FDA's current process for selecting national priority voucher recipients?
Very transparent and predictable
Somewhat transparent and predictable
Neutral
Vague and unpredictable
Highly vague, potentially leading to future litigation
4.
If your company received a priority voucher, would it be ready for market launch in 2 months?
Yes, highly likely
Somewhat likely
Somewhat unlikely
No, highly unlikely
5.
Which drug development process would be easiest for your organization to scale up quickly?
Chemistry, manufacturing, and controls (CMC)
Compliance/Regulatory
Supply chain
Commercialization
Post-market safety monitoring
Other (please specify)
6.
Can a thorough FDA review assessing safety and quality be completed in 1-2 months?
Not at all
Probably not
Maybe/Unsure
Probably
Definitely