US FDA seeks feedback to draft guidelines on product classification
This article was originally published in Clinica
Executive Summary
The US FDA has issued for public consultation two related draft guidelines on product classification issues including classifying medical products as drugs or devices and interpreting the term "chemical action" in the context of medical devices.
You may also be interested in...
FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say
The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.
Combo Product Classification Guidance Doesn't Fix All Existing Problems, Experts Say
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.
EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.