It took the US Food and Drug Administration (FDA) 5 years to complete capability assessments of the 28 EU Member States under a transatlantic Mutual Recognition Agreement (MRA) for pharmaceuticals. With the FDA’s recognition of Slovakia on Thursday, 11 July, this has been done: all regulatory authorities of the Twenty-Eight are now recognised by the FDA - which has been reciprocal since June 2017 when the EU determined the same about the FDA.
Rather than having to carry out their own...