New Drug Application

Aerie to build manufacturing facility in Ireland

Aerie to build manufacturing facility in Ireland

By Dani Bancroft

Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.

US FDA launches quality office

US FDA launches overarching Office of Pharmaceutical Quality

By Zachary Brennan

Industry won’t see much of an initial impact from the US FDA’s newly formed Office of Pharmaceutical Quality, though in a couple of years the agency will have more benchmarks and new technology to find and single out the worst manufacturers. 

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