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		search within: All Publications Medicare Drug Focus "The Blue Sheet" "The Gold Sheet" "The Gray Sheet" Medicare Guide "The Pink Sheet" "The Pink Sheet DAILY" "The Rose Sheet" "The Silver Sheet" "The Tan Sheet" Health News Daily Pharmaceutical Approvals Research Policy ALERT Washington Fax   A D V E R T I S E M E N T  August 2008 Volume 13, Number 8  Tracking Troubled NDAs: New FDA Regs Mean Less Clarity For Investors After an 11-year process, FDA is doing away with “approvable” and “not approvable” letters. The new name (“complete response”) gets rid of the negative connotations of “not approvable.” But it is likely to create more confusion – and less transparency – for investors and the public... Read More>> J&J’s Doribax Is Subject Of FDA’s First "Complete Response" To An NDA ... Read More>> CDER New Drug Reviews Are At 80%-90% Of User Fee Goals, Jenkins Says ... Read More>> Sanofi-Aventis Pares Pipeline, Ditches Antidepressant Amibegron In light of clinical setbacks and a broader overhaul, Sanofi-Aventis has ended some once-promising advanced development programs, while the fates of others hang in the balance, pending study results and strategic reviews. ... Read More>> R&D In Brief ... Read More>> Mircera Review Provided FDA With Forum To Suggest Ideal ESA Studies With FDA’s review of Roche’s Mircera BLA, the agency went beyond the normal evaluation leading to approval of the drug; it seized the opportunity to weigh in on the proper development of erythropoiesis-stimulating agents.... Read More>> Mircera Clinical Development ... Read More>> Mircera FDA Reviewers ... Read More>>   Discovery Labs makes progress with Surfaxin   Centocor’s ustekinumab delayed   Novel blood clot drug Xarelto filed in U.S.   Durect oxycodone drug Remoxy gets priority review   June 2008 Approvals  ... Read More>>     June 2008 Supplements  ... Read More>>     June 2008 Abbreviated  ... Read More>>     Estimated FDA User Fee Review Goals For Pending NDAs/BLAs... Read More>>     Biologics Approved In 2008... Read More>>     New Molecular Entities Approved In 2008... Read More>>     Advisory Committee Recommendations... Read More>>     "Approvables" & "Complete Reviews"... Read More>>

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