Home - RAPS Regulatory Exchange

See what's new in the Regulatory Open Forum

RE: Extending Clinical Dosing Beyond 13 weeks without completing 9-month non-rodent repeated dose tox ...

Posted by: Olga Peycheva, an hour ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello, I agree with Glen and I would add that the best way is to ask FDA. I have a client who is currently running additional toxicology study in parallel with the current study but they have FIH data. read more
RE: Can Usability Validation be conducted as Part of an Animal Study

Posted by: Ronald Boumans, 4 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

For the usability evaluation you must define typical users and use scenarios. If you can cover all of those with an animal study, that would be fine. However, I have my doubts and I can't think of a scenario read more
RE: Medical Device End of Life Plan

Posted by: Richard Vincins, 4 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Good day Anon, I posted previously concerning a basic structure of an "end of life" plan for a medical device if you search a little. The end of life plan needs to be structured according to type of read more
RE: FDA Devices and Accessories Listing

Posted by: Richard Vincins, 4 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Hello Anon, Medical device listing in the United States is fairly flexible highly depending on how the product and any accessories are structured. There are other purposes for the medical device listing read more
RE: Conferences

Posted by: Edwin Bills, 5 hours ago

Discussion

Found in: Regulatory Open Forum Discussions

Not sure what area is your area of interest but there is a series of conferences co-sponsored by RAPS and AFDO and FDA that may be well worth your time. Those organizations picked up the Xavier Health read more

View this profile on Instagram

RAPS (@regulatoryprofessionals) • Instagram photos and videos

Unanswered posts

MedSafe EFT Setup Activation

By: Anonymous Member , 14 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Hello, We are trying to file DMF via Medsafe in NZ. Medsafe requires EFT system to file the DMF. Has anyone faced any issues activating EFT system from Medsafe especially when all the information ...
Alcochol (ethanol) interaction study

By: Anonymous Member , 14 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous I would appreciate it if anyone who has experience with Alcohol interaction studies could provide further guidance to my question. One approach to this study would be to use an ...
Jamaican Medical Device Registation

By: Anonymous Member , 21 hours ago

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Looking for information regarding Jamaican Device Registration. Specifically the cost and lead time for registration of Class 1 products.
Data to support shipping refrigerated drug product ...

By: Anonymous Member , yesterday

Posted in: Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Dear RAPS Forum, The storage conditions for our commercial drug product, which comes in 3 fill volumes, is 2-8C. As per USP 659, we ship the product under refrigerated conditions. We want ...
New research on the global regulatory workforce

By: Ryan Connors , yesterday

Posted in: Regulatory Open Forum

Along with elemed , RAPS has published the 2024 Report on The Global Regulatory Affairs Professionals Workforce. The second edition of this ground-breaking white paper provides a snapshot of the size and health of the regulatory affairs profession. ...