滚动提交 NDA 和 BLA：加快审阅时间表
Accelerate your FDA review process with a rolling NDA/BLA eCTD submission with Certara’s GlobalSubmit eCTD software and eCTD publishing specialists
Author: Evan Richardson
Study Tagging Files: What’s the Right Duration for Study Metadata?
When submitting nonclinical study reports in regions using Study Tagging Files (STF), the duration of the study is one common piece of metadata that must be provided. The ICH eCTD STF Specification provides three options to choose from – short, medium, and long. But the ICH eCTD STF Specification doesn’t define the time periods covered by … Continued
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 … 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
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
Best Practices for Placing Drug Master File Reference Letters in Regulatory Applications
Within drug applications (ANDA, BLA, IND, or NDA), eCTD (electronic common technical document) Module 3 pertains to quality data. It has become increasingly common for sponsors to reference a Drug Master File (DMF) within this module. A DMF contains detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drugs … Continued
Rules for Submitting Electronic DMFs to FDA, Health Canada
Rumors of rules governing Drug Master File (DMF) submissions are swirling. I’ve heard a pair of questions lately. “Do I need to resubmit my DMF files in eCTD format?” “Should I resubmit my files electronically?” The answer depends on the agency. The U.S. FDA and Health Canada have each updated their submission requirements for … Continued
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