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 … Continued

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. The accepted practice is to include two copies of the form in your submission: An unsigned copy of the fillable form, to be used by FDA to … Continued

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 … Continued

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 … Continued

The Many Challenges of Narrative Writing

Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing. A large narrative project is typically divided into several stages, within which each individual function typically works within a certain pre-defined budget, set of tasks, and labor allocation silo: The biostatistics group produces Tables, … Continued

DIA’s RSIDM Ask The Regulators Session: What We Learned

DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two … Continued

Tips For A Successful eCTD Conversion

With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion. It is important to note that once an eCTD submission has been made to an application all subsequent submissions to that application must also be … Continued

How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards

Editor’s Note: This is the first in a series of posts related to the Identification of Medicinal Products (IDMP) written by CAPT Vada A. Perkins (ret) that will appear on the eCTD Summit. Mr. Perkins is the Founder and Managing Principal of IDENTIFICA, a global life sciences consulting and IT firm specializing in global product … Continued

CDISC Data Standards: Understanding the Guidance for Standardized Study Data

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. The study data requirement is not retroactive and will only apply to … Continued

FDA to Introduce New Validation Errors for Study Data

FDA is planning to introduce new eCTD validation criteria it will use to enforce requirements for clinical and non-clinical study data submitted electronically. The study data validation errors (2 High, 2 Medium) will apply to the following eCTD sections – 4.2 Study Reports and 5.3 Clinical study reports and related information. FDA is asking sponsors … Continued

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