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Updated Form FDA 1571

FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018.

Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA...

Trial Summary Dataset: An Overview

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Trial Summary dataset has become increasingly useful to reviewers.  The Trial Summary (TS) dataset allows the sponsor to submit a high-level overview of the trial in a structured format. Each record in the Trial Summary dataset contains the value of a parameter, a characteristic of the trial. For example, a Trial Summary dataset is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The Trial Summary dataset contains information about the planned and actual trial characteristics.

Creating an ESG Account: Tips for Success

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office. Creating an ESG account requires many steps. This post provides helpful tips for the successful creation of your ESG account. 

NeeS: A Thing of the Past

With 2018 well underway, if you’re still not submitting in electronic Common Technical Document (eCTD) format in Europe, now is the time to transition. Non-eCTD electronic Submission or “NeeS” have been accepted for many years. However, they are becoming less common for National Procedures. Furthermore, at the end of this year, NeeS will be a thing of the past.  On 10 March 2017, the European Heads of Medicines Agenices (HMA) announced that eCTD will be mandatory for all regulatory activities in National Procedures as of January 1, 2019.

How to Avoid Validation Errors on Scanned FDA Forms

Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms.

EMA Reasons for Rejection of CCI

New data from European Medicines Agency (EMA) confirms the tough position EMA is taking in regard to commercially confidential information (CCI). According to the European Medicines Agency’s “EMA Update on Clinical Data Publication” published on 29 January, 2018, 76% of CCI instances were rejected in 2017. Interestingly, the EMA has provided further insight on how they are considering CCI by citing five reasons for rejection.

New FDA Forms 356h and 1571

In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it can be difficult to tell if you have the current version of these forms because FDA did not update the expiration date for either document.