By Mary Waters, Senior Consultant, eCTD Publish Services

The FDA updated their Form FDA 1571 and Form FDA 356h in May 2018 to include a few new fields; 6B, 7B, and 15B. This change on the Form FDA 1571 now includes the SNOMED CT Indication Disease Term. SNOMED CT is the acronym for Systematized Nomenclature of Medicine Clinical Terms.

SNOMED International established in 2007 and is responsible for determining the global standard for healthcare terminology. SNOMED CT is considered the most comprehensive and multilingual terminology for clinical healthcare worldwide and is the basis and general core terminology for all electronic health records. There were more than 30 countries involved in contributing, developing, and maintaining SNOMED CT. The FDA has adopted this terminology standard for coding study indications for submissions such as IND, NDA, BLA, and ANDA.

The primary purpose of using SNOMED CT is to encode the meanings in health information, support effective clinical records, provide consistent information in data. Using SNOMED CT allows for a consistent manner to index, store, retrieve and aggregate clinical data across specialties and care sites. These consistent terms are also used in representing the medical conditions in Structured Product Labeling (SPL).

The SNOMED CT nomenclature includes clinical findings, symptoms, diagnoses, procedures, body structure, organisms and other etiologies, substances, pharmaceuticals, specimens, and devices.

To complete the Form FDA 1571, ensuring the completed form passes validation and is not rejected, it’s best to go directly to the SNOMED International website which is found at http://browser.ihtsdotools.org/.

There are currently nine editions to choose from, but for US FDA purposes, please select the United States Edition. Also, please note that the website states that Internet Explorer will not work and to use Google Chrome.

After you have chosen the US Edition, the next page will show you tab choices of Taxonomy, Search, Favorites, and Refset. The next set of tab choices are the Concept Details: Summary, Details, Diagram, Expression, Refset, Members and References.

Using the Search box, if you type in the term “migraine”, the program provides 156 matches for this term, which could be further grouped or filtered. The US National Library of Medicine (NLM) maintains a module of core metadata concepts which is indicated by a US Flag icon.

When completing the Form FDA 1571, the agency is looking for both the Concept Code (e.g. 37796009) and the Disorder (e.g. Migraine). This is the information needed to complete Field 7B.

The other notable change to the Form FDA 1571 is the addition of Field 6B. You now need to indicate if your submission is Commercial or Research. If you select Commercial, you are stating that the product(s) are under investigation that are intended to be commercialized at a later time; and Research is defined as products under investigation that will not or are not intended to be commercialized at a later time. With this change, the FDA is now requiring that commercial INDS will be formatted in eCTD.

The FDA is refining their processes for preparing electronic submissions. These changes should make doing business with them easier, especially for those who are new to this area. If, however you or your firm still need some help after reviewing the instructions, please reach out to us. We can help you not only interpret or choose the appropriate code(s) to use but can also help you properly complete the form. Remember, we are only just a phone call away!

 

 

 

Nitisha Pyndiah - Biotech Consulting Services

Mary is an expert provider of electronic Common Technical Documents (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic submissions through the FDA ESG.