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. …

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: …

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 …