Blog
RSS FeedPosted by Michael Wonder on 26 Oct 2021
Eyenovia announces reclassification of MydCombi as drug device combination product by FDA
25 October 2021 - Company received complete response letter with additional requests and is preparing necessary documents for expedited resubmission, ...
Posted by Michael Wonder on 08 Oct 2020
NDA submission for Polarean’s hyperpolarised 129 Xenon gas drug-device diagnostic for lung imaging
7 October 2020 - Polarean Imaging announces its submission of a new drug application and request for priority review to the ...
Posted by Michael Wonder on 07 Dec 2017
FDA seeks to speed approvals of generic drug-device combos
5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...
Posted by Michael Wonder on 15 Nov 2017
First digital pill approved to worries about biomedical ‘Big Brother’
13 November 2017 - For the first time, the FDA has approved a digital pill — a medication embedded with ...
Posted by Michael Wonder on 27 Apr 2016
FDA issues complete response letter for digital medicine new drug application
26 April 2016 - Otsuka and Proteus Digital Health today announced that the US FDA has issued a complete response letter ...