Sentences with phrase «processing new drug applications»

Simply put, the industry believed that the FDA was eating up the length of its patents, and profits, because of its slowness in processing new drug applications.

Not exact matches

This designation enables Aura to have more frequent interactions with the FDA throughout AU - 011's drug development process, as well as priority review of the New Drug Application (Ndrug development process, as well as priority review of the New Drug Application (NDrug Application (NDA).

There also could be arguments made for regulating cell - cultured meat under FDA's New Animal Drug Application process.

Discussions with the US Food and Drug Administration (FDA) have confirmed that safflower - produced insulin is eligible to follow a shortened drug approval process and we have filed an Investigational New Drug (IND) application to the Drug Administration (FDA) have confirmed that safflower - produced insulin is eligible to follow a shortened drug approval process and we have filed an Investigational New Drug (IND) application to the drug approval process and we have filed an Investigational New Drug (IND) application to the Drug (IND) application to the FDA.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the applicatDrug Application by the manufacturer of the drug, and FDA review and approval of the aApplication by the manufacturer of the drug, and FDA review and approval of the applicatdrug, and FDA review and approval of the applicationapplication.

We find out how advances are deepening our understanding of cancer biology and resistance processes, which will lead to new clinical applications such as non-invasive biomarkers and drug development.

... [I] f a method of treatment consisting in the application of a new drug could be claimed as a process apart from the drug itself, then the inventor, by making such a process claim, would have an easy way out of the restriction in s. 41 (1).