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    RE: eIFU Services

    That is an excellent question!  It would really help if it were expanded to anything but home use devices, which is consistent with a lot of other countries. ------------------------------ Tina O'Brien RAC, MS Director of Regulatory Affairs Airport Oaks New Zealand ------------------------------

  • For the budget minded, shop around for your standards! The Estonian Standards Service provides standards in English at very affordable rates: https://www.evs.ee/en/search ------------------------------ Karen Long RAC Vancouver BC Canada ------------------------------

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    RAC EU Exam

    Hello, Hope you all are doing well. Does any one appeared for RAC EU exam? If so, can you share any study material or practice test? Thanks a lot in advance.  Kind Regards,  Vidita Desai ------------------------------ VIDITA DESAI Sr. Regulatory affairs Specialist Jersey city NJ United States ------------------------------

  • Looking for insight on providing the FDA ORA District Office field copy notification that an eCTD NDA CMC supplement has been submitted...is it still required to send a hard copy or can the letter be sent via email? Thank you! ------------------------------ Bridgette Kunst MA, RAC Managing Director bkunst@bridgereg.com --------------------------- ...

  • Hi Ken, You can request the pIND number as well as submit pre-submission documents (i.e. pre-IND meeting request/briefing document) via the CDER NextGen Portal under "FDA Alternate Submission":  https://edm.fda.gov/EDMIDPLogin/welcome?response_type=code&client_id=0oa1as7rb2poiYTch297&scope=openid%20profile&state=1077959211_1594499771930&redirect_uri=https%3A%2F%2Fedm.fda.gov%2Foidcclient%2Fedmrp ...

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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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