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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FDA Provides Clarification for Organizations Submitting ANDAs

The Generic Drug User Fee Amendments (GDUFA) introduced user fees to the organizations participating in the bioequivalent drug industry and incentivized filing Abbreviated New Drug Applications (ANDAs) electronically. The law functions as an informal mandate by promising expedited review times to applicants who submit to the US FDA in eCTD format. Another GDUFA stipulation addressed the Refuse-to-Receive (RTR) designation for ANDA...

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Notes from RAPS Advanced eCTD Workshop

This week’s blog posting is from Rahul Mistry, CEO of GlobalSubmit, who recently was a featured speaker at the RAPS workshop entitled “Advance eCTD Submissions”.  Rahul’s presentation focused on eCTD quality, a topic that obviously interested the audience based on the significant number of questions that he received. Two weeks ago I had the pleasure at presenting at an Advanced eCTD Workshop hosted by RAPS in...

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FDA to Reject eCTDs with Significant Technical Issues

Due to the increased adoption of the eCTD and number of submissions received by the U.S. FDA, submission quality is receiving increased focus and attention at the U.S. FDA. In recent conversations with FDA officials, they have expressed a commitment to increase their diligence and oversight with respect to submission quality and have signaled their intention to begin rejecting eCTD sequences having significant technical issues....

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