The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique ...

On June 21, 2017, FDA communicated their intent to ensure that patients are not being priced out of the medicines they ...

The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA ...

News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT ...

As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow ...

Gartner, the world’s leading information technology research and advisory company, predicts that IT spending in the ...

In September 2016, the FDA published new deadlines on electronic submissions: May 5, 2017: NDA, BLA, ANDA and DMFs must ...