IND = Investigational New Drug
NDA = New Drug Application
Applying for IND one is asking for agreement to study in Clinical Trials
(on humans) a new drug, biological, or device. Applying for NDA, one is
asking for marketing approval of this new entity. Usually, marketing
agreement is asked for one or two indications. Additional indications
are requested with supplemental applications. Completely new indications
require new NDA. Not always, though.
Hope it helps.
Nenad
Jeanne Lenzer wrote:
>
> I'm a tad embarrassed to have to ask this, but I was unable to find this
> out on my own -
>
> A drug that's approved for one indication and the manufacturer wants to
> have it approved for a new indication needs to get an NDA or an IND? I
> thought it was an NDA but I'm aware of a major drug that is undergoing IND
> approval by the FDA and it's already in use for another indication. Can
> someone 'splain me how this works? I need to interview an author soon
> about this. any help is appreciated.
>
> thanks
> jeanne
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