Expectations for the Implementation of eCTD v4

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 fourth in a series on the Next Major Version (NMV) of eCTD, eCTD v4.0, which is based on the RPS standard. On December 15, 2015, the International Conference … 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

The Role of a U.S. Agent

Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in … Continued

Submitting eCTD in Advance of a Milestone Application

While advanced GPS systems and the advent of Big Data analytics are negating some of their advantages, early birds are still capturing worms at a good clip. We’ve heard this slogan since childhood. For those of you planning to implement eCTD, the early bird’s experience rings true. Many people erroneously believe that your first eCTD … Continued

Rolling eCTD Submissions a Good Fit for Expedited FDA Programs

The idea of a rolling submission, or rolling review, for a Biologics License Application (BLA) or New Drug Application (NDA) is not new. In fact, the concept was introduced as the U.S. Food & Drug Administration (FDA) implemented the Modernization Act of 1997. A rolling submission is done in waves. Sponsors submit completed sections for … Continued

Placement of DMF Reference Letters

Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the … 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

Q&A – Ad Promo Submissions

Editor’s Note: Below are responses to the questions submitted by members of industry during GlobalSubmit’s Module 1 Education Series – M1 Effect on Ad Promo Submissions Webinar on June 16, 2015. 1. Now that industry is able to submit OPDP submissions in eCTD format, can you foresee any issues/challenges when a sponsor and a partner … Continued

Hyperlinking: Making the Most of Navigation in eCTD Submissions

When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards … Continued

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