Submitting eCTD in Advance of a Milestone Application
May10

Submitting eCTD in Advance of a Milestone Application

Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.

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Rolling eCTD Submissions a Good Fit for Expedited FDA Programs
Apr13

Rolling eCTD Submissions a Good Fit for Expedited FDA Programs

A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.

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Transparency Vital to Regulatory Publishing Projects
Nov19

Transparency Vital to Regulatory Publishing Projects

Agile relies on transparency. Decisions to optimize value and control risk are made based on the perceived state of the artifacts. To the extent that transparency is complete, these decisions have a sound basis. To the extent that the artifacts are incompletely transparent, these decisions can be flawed, value may diminish and risk may increase.

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Submission Tracker, Issue Log Key to Agile Regulatory Publishing
Nov05

Submission Tracker, Issue Log Key to Agile Regulatory Publishing

The Submission Tracker is a list of every document that will be submitted to an Agency. The Submission Owner is responsible for the Submission Tracker, including its content, availability, table of contents sections, document production date, title, ordering and status of the document in the publishing process. For simple submissions (e.g. small amendments) the Submission Tracker could simply be a list of documents. Either way the Submission Tracker should have attributes that help estimate the publishing effort

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Managing Regulatory Publishing Projects Using Agile
Oct22

Managing Regulatory Publishing Projects Using Agile

When following the Agile Methodology for Regulatory Submissions, events are used to create regularity and to minimize the need for meetings outside of the methodology. All events are time-boxed, meaning every event has a maximum duration. Once a Sprint begins, its duration is fixed and cannot be shortened or lengthened. The remaining events, such as Daily Stand Up Meetings, may end early if they have achieved their purpose, but cannot run over the allotted time. Such an approach ensures that an appropriate time is spent without introducing wasted effort into the process.

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Agile Regulatory Publishing Team
Oct08

Agile Regulatory Publishing Team

A team using the Agile for Regulatory Submissions methodology consists of a Submission Owner, Publishing Team, and a Submission Coordinator. Agile teams are self-organizing and cross-functional. Self-organizing teams choose how best to accomplish their work, rather than being directed by others outside the team. Cross-functional teams have all competencies needed to accomplish the work without depending on individuals outside of the team structure. The team model integral to Agile for Regulatory Submissions is designed to optimize flexibility, creativity, and productivity.

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