DIA’s RSIDM Ask The Regulators Session: What We Learned
Feb20

DIA’s RSIDM Ask The Regulators Session: What We Learned

DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two such sessions in addition to the FDA presentations on PDUFA...

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FDARA Marketing Status Reports Due
Jan31

FDARA Marketing Status Reports Due

Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.

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Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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Dissecting eCTD 4
Jun23

Dissecting eCTD 4

Much fanfare has surrounded the Next Major Version (NMV) of eCTD or eCTD 4 since the group I chaired formed in 2005 and developed initial requirements for the standard. You’ve likely sat in on eCTD 4 presentations at industry conferences and heard secondhand of the deliberations, ballots and revisions going on behind the scenes. In short, we’ve all been waiting for things to happen. Well, things have happened. As a member of the Expert Working Group (EWG) first tasked with developing eCTD 4, I’m proud to report that agencies, vendors and sponsors in each ICH region can get started on implementation. ICH announced that it had reached Step 4 and adopted a harmonized guideline on the eCTD 4 Implementation Package for Modules 2 through 5. Let’s review some of the key concepts of eCTD 4 to get an idea of what will change when this standard is implemented down the road.

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Signs Point to Stricter Enforcement of FDA Fillable Forms
May31

Signs Point to Stricter Enforcement of FDA Fillable Forms

In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 3674. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically. Using industry presentations and guidance documents, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.” Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.

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