Sentence examples for approval dossier from inspiring English sources

This detection method, as well as the associated reference materials is an integral part of the approval dossier.

In registration and post-approval dossiers, success has been variable and inconsistencies between agencies and in some cases within the same agency (on different products) have been observed.

The 510 K premarket notification, premarket approval (PMA), design dossier under the Medical Device Directive process, regulations and procedures are delineated.

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.

19 20 For new drugs, the online dossier includes the approval order, product label and drug approval package, which includes summaries of the agency's medical, chemistry, pharmacology, statistical and microbiology reviews.

Table 3 illustrates several potential strategies for inclusion in the initial and post-approval (PA) registration dossiers globally (Colgan et al., 2014; Freed, 2016; Timpano et al., 2017).

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.

Ivomec® oral was considered the reference product (RF) as it was the pioneer first authorized product with a full dossier (NADA 131 392; approval date: July 26 , 1988.

Because biosimilars are the copies of molecules that have already been approved through a rigorous clinical trial program, the dossiers for their approval are reduced compared to those of the originators.

He was happy to proclaim that Blix, the former head of Unmovic, had given the dossier his seal of approval.

Approval required submission of a gene dossier to the UK Genetic Testing Network.