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  • Yemi Ijose Regulatory Affairs Senior Manager GC America Inc. ...

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    Drop Ship Medical Device in Europe, even though we ...

    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 ...

  • 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 ...

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    IND Module 3 versioning?

    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 ...

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    Dear Dr Letter

    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 ...

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