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The letters were intended to let manufacturers know how much work is needed on their applications. [1] Non-approval letters were rejections of a drug's application. [2] Approvable and non-approvable letters were covered under Title 21 of the Code of Federal Regulations, section 314.110. [3]
Procuration (from Latin procurare 'to take care of') is the action of taking care of, hence management, stewardship, agency. The word is applied to the authority or power delegated to a procurator, or agent, as well as to the exercise of such authority expressed frequently by procuration (per procurationem), or shortly per pro., or simply p.p. [1]
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 not be approved in its present form. [1]
A statement of work (SOW) is a document routinely employed in the field of project management.It is the narrative description of a project's work requirement. [1]: 426 It defines project-specific activities, deliverables and timelines for a vendor providing services to the client.
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Power of attorney. A power of attorney (POA) or letter of attorney is a written authorization to represent or act on another's behalf in private affairs (which may be financial or regarding health and welfare), business, or some other legal matter.
For example: ctd-123456/0000/index.xml The purpose of this file is twofold: Manage meta-data for the entire submission; Constitute a comprehensive table of contents and provide corresponding navigation aid.
Maker-checker (or Maker and Checker or 4-Eyes) is one of the central principles of authorization in the information systems of financial organizations. The principle of maker and checker means that for each transaction, there must be at least two individuals necessary for its completion.