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Axendia Industry Brief: FDA’s Digital Transformation Journey

A Roadmap to the Agency’s Modernization Action Plans “We’re not talking about PDFs and digital paper”, affirmed Dr. Abernethy. “We’re talking about digital transformation, use of cloud technologies, use of shared inter-operable data, digitized information.” -Amy Abernethy, M.D., Ph.D., former Principal Deputy Commissioner & Acting Chief Information Officer As Life-Science manufacturers embrace new technologies to … Continued


FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing complete and fileable abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to … Continued


FDA’s New Module 1 is a Bridge to eCTD 4

Editor’s note: Jason Rock served as Project Lead for the HL7 RCRIM Expert Working Group that developed the Regulated Product Submissions (RPS) standard. This post is the third in a series on the Next Major Version (NMV) of eCTD, eCTD 4, which is based on the RPS standard. The evolution of the Electronic Common Technical … 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


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

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