Dictionary » N » Nda

Nda

nda

New drug application An application to the fDA for approval to market a drug in the U.S. The FDA determines if a protein pharmaceutical is considered a drug or a biologic and whether an NDA or a pLA, respectively, should be filed to obtain marketing approval.


Please contribute to this project, if you have more information about this term feel free to edit this page



Results from our forum


pharmaceutical biotechnology

... drug that is being directed to the tumor by the mcAb to which it is conjugated. Most likely it is the use of the cytotoxic drug that requires the NDA. All of the other agents you list are strictly antibodies and, as such, are biological agents only. I suspect most uses of antibodies will be covered ...

See entire post
by kcnq1ot1
Tue Nov 27, 2007 3:41 pm
 
Forum: Molecular Biology
Topic: pharmaceutical biotechnology
Replies: 6
Views: 9162

pharmaceutical biotechnology

... drug that is being directed to the tumor by the mcAb to which it is conjugated. Most likely it is the use of the cytotoxic drug that requires the NDA. All of the other agents you list are strictly antibodies and, as such, are biological agents only. I suspect most uses of antibodies will be covered ...

See entire post
by blcr11
Tue Nov 27, 2007 3:08 pm
 
Forum: Molecular Biology
Topic: pharmaceutical biotechnology
Replies: 6
Views: 9162

pharmaceutical biotechnology

Any synthetic, small molecule used as a drug needs an NDA approval before it can be marketed. The NCI is concerned with cancers, so its language was with reference to cytotoxic/cytostatic agents. The same applies to antibiotics or anti-inflammatory ...

See entire post
by kcnq1ot1
Tue Nov 27, 2007 2:47 pm
 
Forum: Molecular Biology
Topic: pharmaceutical biotechnology
Replies: 6
Views: 9162

pharmaceutical biotechnology

Any synthetic, small molecule used as a drug needs an NDA approval before it can be marketed. The NCI is concerned with cancers, so its language was with reference to cytotoxic/cytostatic agents. The same applies to antibiotics or anti-inflammatory ...

See entire post
by blcr11
Tue Nov 27, 2007 2:21 pm
 
Forum: Molecular Biology
Topic: pharmaceutical biotechnology
Replies: 6
Views: 9162

pharmaceutical biotechnology

(New Drug Application for cytotoxic/cytostatic agents or a Biologic License Application for biological agents) NDA for cytotoxic/cytostatic agents?

See entire post
by kcnq1ot1
Tue Nov 27, 2007 2:16 pm
 
Forum: Molecular Biology
Topic: pharmaceutical biotechnology
Replies: 6
Views: 9162
View all matching forum results

This page was last modified 21:16, 3 October 2005. This page has been accessed 1,894 times. 
What links here | Related changes | Permanent link