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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 ------------------------------

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 ...