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Solid Converter PDF is document reconstruction software from Solid Documents which converts PDF files to editable formats. Originally released for the Microsoft Windows operating system, a Mac OS X version was released in 2010. The current versions are Solid Converter PDF 9.0 for Windows and Solid PDF to Word for Mac 2.1.
However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Word ever since. Pertaining file extensions include:.docx – Word document.docm – Word macro-enabled document; same as docx, but may contain macros and scripts.dotx – Word template.dotm – Word macro-enabled template; same ...
FDA’s 5-19-05 not approvable letter.] The original supplement was submitted 12-19-03 and an approvable letter was issued 6-18-04. A major concern noted in this letter was the failure to establish the optimal dosing strategy for treating this new indication. The concern was that patients might be receiving higher doses than needed.
The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Microsoft Word allows creating both layout and content templates. A layout template is a style guide for the file styles. It usually contains a chapter which explains how to use the styles within the documents. A content template is a document which provides a table of contents. It might be modified to correspond to the user's needs.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
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