Updates to Common FDA Forms
May10

Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of these forms is to download new copies directly from the FDA Forms page on FDA’s website. If you already have...

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Creating an ESG Account: Tips for Success
Apr17

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. 

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How to Avoid Validation Errors on Scanned FDA Forms
Apr03

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.

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EMA Reasons for Rejection of CCI
Mar27

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.

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New FDA Forms 356h and 1571
Mar21

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.

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