Tag Archives: NDA

Engage, But Gently: More Top Line Thoughts on 2014

More Top Line Thoughts on 2014:  Engage, but Gently Two weeks in and the New Year already seems old.  Yet members of our Pharm Exec Editorial Advisory Board are still eager to share their top of line predictions on trends that will shape the industry’s business and reputational assets – forward and backward – over […]
Posted in Op-Ed, Strategy | Also tagged , , , , , , | Leave a comment

Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
Posted in Biotech, compliance, FDA, healthcare, Legal, People, Regulatory, Safety, Strategy | Also tagged , , , , , , , | 1 Comment

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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