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  • Yemi Ijose Regulatory Affairs Senior Manager ... More

  • 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 ... More

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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 ... More

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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 ... More

  • You are making a presentation to the senior management team. You announce that there is no way that the FDA will clear your device in less than 120 days. ... More

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