In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. After the publication of this guidance, all studies with a start date 24 months after the publication date (December 2014) must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions. Study data contained in certain IND submissions must use the specified formats for electronic submission in studies with a start date 36 months after the publication of this guidance.
These requirements pertain to submission of clinical and non-clinical data for studies initiated after December 17, 2016 if you’re filing NDAs, BLAs, and ANDAs. For commercial INDs, the requirement starts after December 17, 2017. In the event an original submission was filed before the requirements went into effect, subsequent submissions (amendments, supplements, and reports) to these types of applications still must meet the requirements.
In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 3674. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically. Using industry presentations and guidance documents, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.” Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.
Jason Rock, Chief Technical Officer at GlobalSubmit, offered great insight into the topic of Regulated Product Submissions (RPS) or eCTD version 4.0 during a free educational webinar jointly hosted by Cato Research and GlobalSubmit, “Background and Drivers to the eCTD Next Major Version / Regulated Product Submission”, on Thursday, October 4th at 1:00 p.m. EDT.
Presentation Details: The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free educational webinar jointly hosted by Cato Research...