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  2. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

  3. List of Microsoft Office filename extensions - Wikipedia

    en.wikipedia.org/wiki/List_of_Microsoft_Office...

    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 ...

  4. Standard for Exchange of Non-clinical Data - Wikipedia

    en.wikipedia.org/wiki/Standard_for_Exchange_of...

    An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.

  5. Document file format - Wikipedia

    en.wikipedia.org/wiki/Document_file_format

    A document file format is a text or binary file format for storing documents on a storage media, especially for use by computers. There currently exist a multitude of incompatible document file formats.

  6. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document [7] requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug ...

  7. Drug Master File - Wikipedia

    en.wikipedia.org/wiki/Drug_Master_File

    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.

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