Hi RexEx Members,
We are starting something that we hope will be a fun way to share some bite-sized pieces of regulatory wisdom on a regular basis: "Tip Tuesday." The idea is pretty straightforward; on Tuesdays, we will share a brief tip submitted by someone in our RAPS community. You will see tips here on RegEx and on RAPS' social media channels. Tips may cover many different aspects of regulatory practice, providing a bit of useful information pertinent to at least some regulatory professionals. Some tips may be relevant to you, and some may not be. Over the long term, we hope to be able to share something helpful to everyone. In the coming days, we will tell you how to submit your own tip. For now, here is the first of what we hope will be many tips to come:
When submitting a request to FDA for orphan designation, don't forget to include copies of all the references (FDA accepts these on CD).
Submitted by William Sietsema
Thanks for the tip,
@William Sietsema.
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org------------------------------