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  • Hi RegEx, If you haven't already heard, RAPS is excited to welcome our newest Chapter: Ontario! To join or learn more visit https://connect.raps.org/ontario/home. Join the Ontario Chapter on Friday, 25 September 2020 from 12 - 1 PM Eastern time for their Virtual Kick-off Networking Lunch! During this networking session, they will introduce ...

  • Labeling of the Drug for investigational use: (21CFR312.6) The immediate package of an investigational new drug intended for use shall bear a label with the statement " Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use "  ( This one sentence is mandatory ) The label or labeling of an investigational new drug ...

  • Peter Kolchinsky is a Managing Partner in RA Capital Management.  For me, enough said. ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ------------------------------

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    submitting one IND with two protocols

    This message was posted by a user wishing to remain anonymous Hello, is it possible to submit a full original IND with two protocols covering two slightly different studies? The rationale is to get feedback on both protocols. Should FDA demand data that is not available yet, is it further possible to withdraw one of those protocols and still get the ...

  • Hi Can somebody help me out. Is there a difference in: " not having regulatory clearance" and "Off-label use". From me personal logic I would say there is no difference, but I might be missing something here. Thank you for your help in advance. ------------------------------ Stefan Maartense MD, PhD Amsterdam Netherlands ------------------------- ...


Volunteer Appreciation 2020

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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