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Dear Dr Letter

Posted by: , 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous We plan to send out a Dear Dr Letter to notify investigators of a new safety event for our investigational drug. Do we need to submit this read more
IND Module 3 versioning?

Posted by: , 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hello, I am working on updating Module 3 sections for an IND as we are beginning Phase 3. This is a clinical-stage biotech and this read more
RE: Certificate of Free Sales (CFS)

Posted by: , 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Fyi, the CFS isn't any kind of exemption. As part of their due diligence they just want to know if you're in good standing with your own read more
RE: GUDID - FDA - Delisting of one of the models - Discontinuation of one of model

Posted by: , 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hello Richard, Thanks for your prompt help. Could you please share FDA guidelines to document 'end of life' plan? Do you have any template? read more
Drop Ship Medical Device in Europe, even though we are a US Company

Posted by: , 2 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hello, I have never been in this situation and think we are in the clear, but just wanted to see if anyone had a different opinion. read more

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Unanswered posts

Do we need to give a dealer proprietary formula in ...

By: YEMI IJOSE , 5 hours ago

Posted in: Regulatory Open Forum

Yemi Ijose Regulatory Affairs Senior Manager GC America Inc. ...
Drop Ship Medical Device in Europe, even though we ...

By: Anonymous Member , 2 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello, I have never been in this situation and think we are in the clear, but just wanted to see if anyone had a different opinion. We are a medical device manufacturing company based ...
Unofficial Medical Device Study Group

By: Karen Underwood , 7 hours ago

Posted in: Regulatory Open Forum

Hi Everyone Just a reminder we will meet this week at 3 pm to 4 pm on Friday. I will present Chapter 8 of EU, from the 5th edition of the RAPS Study Guide. Join Zoom Meeting https://umaryland.zoom.us/j/96213811970?pwd=V2lQeWowQTAxaDc2U2lpU0h3dVZ4dz09 ...
IND Module 3 versioning?

By: Anonymous Member , 2 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello, I am working on updating Module 3 sections for an IND as we are beginning Phase 3. This is a clinical-stage biotech and this is the DS and DP that will be used in registrational ...
Dear Dr Letter

By: Anonymous Member , 2 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous We plan to send out a Dear Dr Letter to notify investigators of a new safety event for our investigational drug. Do we need to submit this Dear Dr. Letter to FDA for review first before sending ...