Tag Archives: unapprovable

No More Approvable Letters: An Expert's Take

In response to last week’s blog about FDA’s announcement that, in future reviews of NDAs, it will ditch approvable and nonapprovable letters for “neutral” complete-review letters, Russ Somma sent an interesting and informative take on the likely effect of the new system on the industry. Somma is president of SommaTech, a pharmaceutical development technology consulting […]
Posted in R&D, Regulatory, Safety | Also tagged , , , , , , | 1 Comment
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