Tag: FDA

read more about Stability storage for combination products
Stability storage for combination products

Stability storage for combination products

The rapidly accelerating demand for combination products continues to drive technological advances in merging product types. However, the convergence of pharmaceuticals with medical devices brings a host of new challenges in stability studies and storage. At a high level the FDA defines combination products as “therapeutic and diagnostic products that combine drugs, devices, and/or biological … Continued


read more about HPRA & FDA Mutual agreement between EU and US

HPRA & FDA Mutual agreement between EU and US

Multual Recognition Agreement (MRA) HPRA / Ireland has been listed by the US Food and Drug Administration (FDA) as part of the mutual recognition agreement between the EU and the US