Sentences with phrase «under new drug applications»

In calendar year 2014, the FDA's Center for Drug Evaluation and Research (CDER) approved 41 novel new drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).

Not exact matches

Slavitt said EpiPen has patent protection, has no Food and Drug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name dDrug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name ddrug application,» all of which make it a brand - name drugdrug.

Celgene Corporation (NASDAQ: CELG) is under continued stock pressure Wednesday after the U.S. Food and Drug Administration rejected its New Drug Application for ozanimod in the treatment of relapsing multiple sclerosis.

Under this system, drug and device manufacturers pay the FDA user fees totaling more than $ 300 million — to be increased under the new law to at least $ 400 million — each year in exchange for speedier review of their applicatUnder this system, drug and device manufacturers pay the FDA user fees totaling more than $ 300 million — to be increased under the new law to at least $ 400 million — each year in exchange for speedier review of their applicatunder the new law to at least $ 400 million — each year in exchange for speedier review of their applications.

He has initiated multiple trials under investigational new drug applications using infused T cells and natural killer (NK) cells.

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

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

In particular, he counsels clients in Abbreviated New Drug Application (ANDA) cases under the Hatch - Waxman Act.