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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:7611006Orig1s000 STATISTICAL REVIEW(S)STATISTICAL REVIEW AND EVALUATION Biometrics Division: VI761100 0000 October 20, 2017 SB3 (proposed
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Who needs nda 211970 accelerated approval?
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What is nda 211970 accelerated approval?
NDA 211970 accelerated approval is a process by which the FDA expedites the review of new drugs that address unmet medical needs.
Who is required to file nda 211970 accelerated approval?
The pharmaceutical company developing the new drug is required to file nda 211970 accelerated approval.
How to fill out nda 211970 accelerated approval?
To fill out nda 211970 accelerated approval, the pharmaceutical company must submit all necessary data and documentation required by the FDA.
What is the purpose of nda 211970 accelerated approval?
The purpose of nda 211970 accelerated approval is to make promising new drugs available to patients more quickly.
What information must be reported on nda 211970 accelerated approval?
On nda 211970 accelerated approval, information such as clinical trial data, safety profile, and drug efficacy must be reported.
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