Innovation on the Rise – The PPH plus Newsletter

In its latest Newsletter, PPH plus provides an update on EMA and FDA new guidelines on innovative and challenging drug development approaches which require a high patient-centered effort.

Thus, the periodical includes the link to the updated fact sheet of the EMA on the development of medicines for orphan diseases, in connection with the framework of the EU’s orphan designation program.

Concerning the US, the newsletter refers to three recent FDA guidelines on medical devices, driven by the increasing deployment of novel digital health tools, as well as to a new FDA guideline on technical considerations for additive manufactured (3D-printed) medical devices.

Additionally, the bulletin informs about the recent EMA approval of the ICH guideline E17 on general principles for planning and design of multi-regional clinical trials that will come into effect in the EU on 14 June 2018.

For further details on the cutting-edge PPH plus services, please contact the PPH plus team directly.


Photography provided by Dr. Dorothé Eisermann