Separate names with a comma.
Hi, I’m trying to find a reliable timeline for FDA’s Emergency Use Authorizations (EUA’s). With FDA’s BLA and NDA applications, it’s 10 months or...
I have a question re FDA’s approval process for Investigational Device Exemption (IDE). On the FDA website, it says it’ll take 30 days or less to...
This thread was suggested by @fireopal and now open for discussion PDUFA dates and FDA Panel Review dates are very important because they are...