Example sentences for: nda
How can you use “nda” in a sentence? Here are some example sentences to help you improve your vocabulary:
Later, when the sponsor has completed its clinical trials program and wishes to apply for marketing approval, it submits its NDA.
The FDA then begins the NDA review process, during which a physician, a statistician, and a pharmacologist, among others, generate lengthy review documents [10].
The sidebar gives an example of how NDA review documents at the FDA give valuable information about paroxetine for anxiety disorders.
However, NDA reviews for many other drug–indication combinations have not been posted: the Prozac Weekly formulation of fluoxetine, clozapine for suicidal behavior in patients with schizophrenia or schizoaffective disorder, and quetiapine for mania, among others.
However, in the interest of making the FDA more “transparent,” and in accordance with the Electronic Freedom of Information Act [11], the FDA has, for the past several years, posted selected NDA reviews for approved drug–indication combinations on the FDA Web site Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm).