Dihydroergotamine Nasal Spray [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-06-26 12:47  – Posting: # 20363
Views: 600

Hi all,


» » If it is required, …
»
» It is. If you would deviate from a guidance without a controlled correspondence you risk an RtR.

It would be an interesting lawsuit, if the company gets an RtR for lack of baseline correction and sues the FDA because the formal requirement is meaningless.
Perhaps a case where FDA could hide behind the fact that it is a draft and contains nonbinding recommendations blahblah?

I could be wrong, but...
Best regards,
ElMaestro

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