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How to Transition from Paper to Electronic Records in a Regulatory Environment - Webinar

2017, January 12

Pharmaceutical » Training

The Electronic Common Technical Document (eCTD) has been the standard, accepted electronic format for NDA, ANDA, IND, BLA, DMF and BMF submissions to the FDA since 2008. The introduction of legacy paper records into an eCTD is accomplished via scanning onto a text readable format. However, there are vast stores of pre-clinical, clinical and drug safety paper records that are archived by many companies for drugs that failed to reach the marketing stage for a variety of reasons. This archived data could support submissions for other new or emerging indications for the drug or support efficacy or safety for related drugs.

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