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Showing posts with label John Jenkins. Show all posts
Showing posts with label John Jenkins. Show all posts
Thursday, December 03, 2009

FDA's Jenkins Sounds Off on Incomplete NDAs

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Earlier this week, FDA issued a Refuse to File on Merck-Serono's cladribine application , meaning the agency felt the NDA was sufficien...
1 comment:
Tuesday, December 23, 2008

Lilly's Prasugrel Widens the Gap

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The gap just got wider. No, we’re not talking about the income inequality gap, or the gender gap, or the generation gap. We’re talking about...
Monday, December 08, 2008

FDA's Internal Advisory Committee Meetings

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Avandia . Vioxx . Ketek . Elidel . Palladone . What do those drugs have in common? The obvious answer is that they are all associated with a...
Monday, September 22, 2008

FDA User Fee Deadlines: Jenkins Expands On Interview Comments

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In a roundtable interview   with top FDA drug officials, Office of New Drugs director John Jenkins said FDA was on track to meet 80%-90% of ...
Friday, August 29, 2008

RFP: Raise Temple's HDL

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HDL-raising is a damaged surrogate. Or at least that's what FDA's Office of Medical Policy director Bob Temple says. And that should...
Monday, June 23, 2008

Prasugrel: Signs Point to FDA Approval

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[Update: Well, it looks like Lilly will have to wait on the champagne, at least for now. FDA extended the review of prasugrel by three month...
1 comment:
Tuesday, May 06, 2008

Setting the Record Straight on Suicidality

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FDA Office of New Drugs Director John Jenkins wants to correct a misperception about testing requirements for psychiatric adverse events. Co...