The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example. What is the CDER NextGen portal? CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal. …
Tag Archives: eCTD
Structured Authoring – Streamlining Regulatory Submissions
It still surprises me that in an industry such as life sciences where quality, compliance and accuracy is of utmost importance, data that can be automatically handled is managed manually. Manual data management is prone to errors, is time consuming and is sometimes even a risky approach of dealing with information across different business functions. …
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New eCTD rejection criteria in force at the FDA
Marketing Authorisation Holders beware! The FDA has just announced that the Center for Drug Evaluation and Research (CDER) will begin rejecting submissions that fail eCTD validation checks 1551 and 1553. Both validation errors are of high severity as described in the eCTD Validation Criteria specification. The different severity levels can be summarised as follows: High: …
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FDA eCTD file formats updated
New opportunities for Pharma companies! Now Pharma companies can use audio and video files to support their promotional material during marketing authorisation applications, making the entire process more engaging. Over the last few months, the FDA has updated the file formats that are permitted within the eCTD. New formats have been added to the file …
Pharma Whisper 