Suggestions(1)
Exact(6)
When a company applies to register a new medicine for an indication that has already been granted for an orphan medicine it is the responsibility of the EMA's Committee for Medicinal Products for Human Use (CHMP) to decide if the new drug is indeed similar to an existing orphan drug, with an application being successful only when the CHMP decides that this is not the case.
In some cases, the U.S. Food and Drug Administration FDAA) may extrapolate an indication that has not been formally investigated for the biosimilar but that is approved for the reference product.
We conclude that the key question is whether to deliberately target and search for disease-causing variations outside the indication that has originally led to the genetic analysis, for instance by using positive lists and algorithms.
Furthermore, drugs that are currently 'approved in all indications' might be prescribed for an indication that has not yet been NICE appraised and might not be recommended by NICE in the future.
The draft guidance states that the FDA may extrapolate to an indication that has not been formally investigated for the biosimilar but is approved for the reference product 7.
All of which is to say: NYC is still the safest large city in America, and there's no indication that has changed.
Similar(54)
This is an indication that having coped with similar symptoms in the past can help during recurrent periods of symptoms.
By all indications, that hasn't stopped system employees from applying a liberal definition of who is at risk.
Nevertheless, efficacy claims must be supported if regulatory approval is to be granted for the wider range of indications that have been proposed for rFVIIa.
One indication of that has been Wall Street's evolving expectations for corporate earnings.
"Every indication that we've had so far is that we were very successful".
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com