However it is believed the paper paid around £150,000 for the complete dossier.
For 21 biocidal products with complete dossiers available from the regulatory authorization process in the EU, confidential information on product composition and a base set of data were provided by the German Environment Agency.
However, some of the notified substances were not further supported by submitting a complete dossiers (e.g., chlorpyrifos, phoxim), so that the actually available number of biocidal active substances is expected to decrease.
As is the case for the development of any new diagnostic or therapeutic drug, this work would take many years and cost millions of euros, requiring the elaboration of a complete dossier, including optimisation of manufacturing and analytical methods, establishment of pharmacological and radiation safety and extensive clinical studies to demonstrate the real clinical value and profit.
Requirements of the biosimilar pathway do not include all elements of a complete dossier for the approval of a new medicine but are more stringent than the requirements for the approval of generics.
He was keeping a complete dossier on the Marcos regime, but he also concocted a scheme for Marcos to edge out of his predicament gradually, "like a hero".
As a case moves from one point to the next, the answers to SDM's questionnaires build a complete dossier.
She said Emed had delayed complying with some of the conditions that had to be met before the project could be approved, particularly requirements for protecting the environment, and had presented a complete dossier for approval only last month.
Perhaps they will not make a complaint nor demand a replay or a free place in the finals until they have compiled a complete dossier or have managed to summon up Football Association of Ireland levels of convenient moral outrage.
On the other hand, though it is generally accepted that a complete dossier would be desirable, sometimes confirmative phase III studies are hard to arrange for ethical or feasibility reasons and most patients with advanced disease cannot wait for the full approval, by which time they would probably be dead.
