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RE: Critical Parts/Components - Critical Suppliers

Posted by: , an hour ago

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Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hello Dan, You nailed it. Very well explained and informative reply. Appreciated - have a great weekend.
RE: Unofficial Medical Device Study Group

Posted by: Robert Falcone, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Thanks for sharing ------------------------------ [Robert] [Falcone] PhD, FTOPRA, FRAPS ------------------------------
RE: Critical Parts/Components - Critical Suppliers

Posted by: , an hour 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. Your feedback always helpful. Appreciated - Have a good weekend.
Sanction countries

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Hi, Does anyone know if there is a resource that can be used to know if any sanctions were placed to do business of medical device or read more
RE: IND Module 3 versioning?

Posted by: , an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

This message was posted by a user wishing to remain anonymous Thank you, Tom. Coming from a clinical background, it surprised me that the M3 documents were not always versioned and dated for FDA, although read more

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Antibody drug conjugate drugs and comparability

By: Barbara Araneo , 5 hours ago

Posted in: Regulatory Open Forum

In this instance a sponsor wishes to proceed to Phase 1 under an active IND where the drug is an antibody (1) drug conjugate. Because Ab1 is not an option for commercialization, the sponsor wishes to obtain an approved comparability protocol to substitute ...
Regulatory Affairs Toastmasters (RAT) Open House

By: Elizabeth Bereza , 5 hours ago

Posted in: Regulatory Open Forum

Join us for our next open house on May 17th! https://www.linkedin.com/events/regulatoryaffairstoastmasters-r7181644189183418369/ ------------------------------ Elizabeth Bereza RAC, MSRA Senior Regulatory Affairs Specialist Indeio LLC Raleigh ...
Sanction countries

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hi, Does anyone know if there is a resource that can be used to know if any sanctions were placed to do business of medical device or drugs by United States in certain countries. ...
SaMD and Pushed Software Patches & Updates

By: Anonymous Member , an hour ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello, I am curious if anyone has any experience with Medical Device Software and pushed or automatic updates and patches. It seems that with the release of the Cybersecurity in Medical ...
Hear from RAPS Power of One participants about the ...

By: Brooke Keith , 6 hours ago

Posted in: Regulatory Open Forum

The RAPS Power of One - 90-Day Member Recruitment Challenge is in full swing. It's our annual recruitment challenge , where RAPS members recruit friends and colleagues to join our society as members.   We thought it might be ...