Here’s a brief overview of who we are and what we do.
We're Your Pharma, Biotech, and Device Partner - Experts in Regulatory Strategy,
Clinical, CMC, and Strategic Program Development
CBR is committed to providing clients with both strategic
and technical consulting in the areas of FDA representation,
strategic program development, clinical program development,
process development, and quality assurance oversight. We have been responsible
for the approval of numerous drugs and biologics in the US since 2002.
FDA News: SNOMED CT
FDA issued revised Form 1571 and Form 356h in April 2018 The 1571 form
is substantially different in many fields.The new Block 7B on the 1571 now requires
inclusion of a SNOMED CT clinical indication disease term. If you are a current client,
or someone interested in learning more about SNOMED CT, feel free to call CBR Regulatory
Affairs at 720-746-1190 for more information. FDA has prepared a short PowerPoint
presentation to also assist you please