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

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

On August 4, 2016, The European Medicines Agency (EMA) hosted a webinar for the industry to further the understanding ...

…is a frequently asked question in the regulatory industry. The legislative EU deadline, 1st of July 2016, has kicked ...

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of ...

EMA eCTD specifications – General Update In October, EMA has officially released the version 3.0 of the European Module ...

Digital transformation is a hot topic. When applied to health products development, being able to combine science and ...