Here is a sampling of the comments, as translated by the Moscow bureau of The Times: "It's obvious to me why the complete dossiers are not open for studying -- probably these dossiers contain reports of informers and documents with signatures of people who issued verdicts, maybe even the names of the executioners.
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.
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.
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.
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.
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.
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.
ECHA was very late in providing aids for examining the completeness of dossiers and fees prior to submission.
So that the Nuisance Committee can complete its dossier before the next General Meeting, please state if you are the Edith Piaf, the two barking poodles," etc.
