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The documentation required in an NDA is supposed to tell "the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged.” [2] Once approval of an NDA is obtained, the new ...
A unilateral NDA (sometimes referred to as a one-way NDA) involves two parties where only one party (i.e., the disclosing party) anticipates disclosing certain information to the other party (i.e., the receiving party) and requires that the information be protected from further disclosure for some reason (e.g., maintaining the secrecy necessary to satisfy patent laws [5] or legal protection ...
[citation needed] Once an IND application is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and clinical trials may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in 21 CFR 312.42 .
The article ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Ponatinib originally appeared on Fool.com. Try any of our Foolish newsletter services free for 30 days .
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Under the PDUFA regime, New Drug Applications and Biologics License Applications (together referred to as 'human drug applications' in the PDUFA context) are levied a fee upon filing. As of 2021 [update] , this fee was US$2,875,842 for applications requiring clinical data and US$1,437,921 for applications that do not. [ 4 ]
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