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New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [ 1][ 2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug ...
The contractor must prioritize the submittal process, submitting and obtaining approval for materials needed for the first part of the project. Present-day submittal software for the construction industry can help streamline that process by grouping submittals by submittal types, using a standard material library, and ability to filter by the ...
Request for information. A request for information ( RFI) is a common business process whose purpose is to collect written information about the capabilities of various suppliers. [ 1] Normally it follows a format that can be used for comparative purposes. An RFI is primarily used to gather information to help make a decision on what steps to ...
Production Part Approval Process (PPAP) is used in the Aerospace or automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP. "All customer engineering design record and specification ...
A mortgage preapproval is a letter or written statement specifying your maximum loan amount and the lender’s commitment to fund the loan if your financial situation remains unchanged.
A Request for Evidence ( RFE) is a request issued by the United States Citizenship and Immigration Services to petitioners for residency, citizenship, family visas, and employment visas. Examples of petitions for which a RFE may be issued are Form I-129 (alien worker authorization), Form I-140 (immigrant worker authorization), and Form I-130 ...
Complete Response Letter. In United States pharmaceutical regulatory practice, a Complete Response Letter (CRL), or more rarely, a 314.110 letter, is a regulatory action by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application or Biologics License Application, indicating that the application will ...
Approvable letters, and the related non-approvable letters (alternately not-approvable letters ), were notifications sent out by the Food and Drug Administration (FDA) to drug manufacturers alerting them to the approval prospects of their drugs under development. [1] The letters were intended to let manufacturers know how much work is needed on ...
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