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The classical clinical endpoints such as survival and progression free survival will have a major role in the later stages of clinical development aiming for proof of efficacy and marketing authorisation.
For orphan drugs, market authorisation is considered proof of additional benefit by German regulations [§35a (1) German Social Code Book V], but only up to an annual revenue of 50 million Euros.
The Lithuanian border guards would accept our letter of authorisation.
The latter required a greater degree of authorisation than a shotgun licence, he said.
Independent watchdog Monitor has ruled James Paget University Hospitals NHS Foundation Trust at Gorleston now meets its terms of authorisation.
The process of authorisation in a company as monolithic as Woolworths is immense.
In future Olympics all competitors seeking authorisation to use asthma medication will have to provide clinical and laboratory proof of their ailment.
The proof of everything.
No proof of creditworthiness.
Proof of concept?
Jann is proof of that.
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