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Prescriber Fax Formally Total Care CAPELLA (vandetanib) (Coverage Determination) This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign
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The full text of PDUFA (Prescription Drug User Fee Act) refers to the legislative text that governs the fees charged by the FDA to drug manufacturers for the review of new drug applications.
Drug manufacturers seeking approval for new drugs are required to file the full text of PDUFA.
Filling out the full text of PDUFA typically involves submitting the required forms and information to the FDA, which may include application data, fees, and specific product information.
The purpose of PDUFA is to expedite the drug review process and ensure that the FDA has the necessary resources to assess new drug applications.
The information that must be reported includes details on application fees, drug formulation, manufacturing processes, and clinical trial results.
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