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Optimizing your ECTD AND Jared Laity, PMP Data Management Solutions Team CDR Office of Business Informatics GDF and You 2014 March 27, 2014, Agenda ECTD History ECTD Requirements and Timeline Getting
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Optimizing your eCTD ANDA involves improving the efficiency and quality of the electronic Common Technical Document for Abbreviated New Drug Application.
All pharmaceutical companies submitting an Abbreviated New Drug Application (ANDA) are required to optimize their eCTD.
To fill out optimizing your eCTD ANDA, companies should follow the specific guidelines provided by the FDA and use the appropriate software tools.
The purpose of optimizing your eCTD ANDA is to streamline the submission process, improve data quality, and facilitate the review process by regulatory agencies.
Information such as product data, manufacturing details, analytical testing results, and labeling information must be reported in the optimized eCTD ANDA.
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