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  • Bayer Prostate Cancer Drug Gains FDA Approval
    ... the product's prescription drug user fee (PDUFA) goal date of August 14, and was reviewed ... Xtandi-also approved three months ahead of its PDUFA date of November 22, 2012-is ...
    5-16-2013
  • Biggest Biotech Trends of 2012
    ... Also in July, President Obama enacted a fifth authorization of the Prescription Drug User Fee Act (PDUFA V), which over FY 2013-17 will collect a total $6.4 billion in biopharma ...
    1-15-2013
  • Getting FDA to Yes
    As PDUFA, patent cliff drive 2012 approvals, can industry keep cranking out new molecules? ... of the Prescription Drug User Fee Act (PDUFA V); more applications for new drug ...
    1-8-2013
  • Biggest Biotech Trends of 2012
    ... Also in July, President Obama enacted a fifth authorization of the Prescription Drug User Fee Act (PDUFA V), which over FY 2013-17 will collect a total $6.4 billion in biopharma ...
    12-26-2012
  • Nuron, Raptor in Royalty Deals
    ... NASH. Raptor has submitted a NDA to FDA, which has assigned a PDUFA date of Jan. 30, 2013; and a Marketing Authorization Application to the European Medicines Agency, respectively. ...
    12-20-2012
  • Exelixis Scores First FDA Approval for Thyroid Cancer Drug
    FDA granted Priority Review Designation to Exelixis' rolling NDA, completed in May. The agency met its Prescription Drug User Fee Act (PDUFA) action date for a decision on the NDA, ...
    11-30-2012
  • Slaying the Fungus Among Us
    ... To help ensure that happens, Congress ended its partisan squabbling long enough earlier this year to pass a fifth authorization of the Prescription Drug User Fee Act (PDUFA V), ...
    11-14-2012
  • Russia Establishes Clinical Trial Hub
    ... In addition, Russia's regulators will have to continue progress toward faster decisions on clinical trials, especially now that FDA has signaled through PDUFA V that it will step ...
    10-18-2012
  • Advice to Biofirms: Be Prepared, Plan Ahead
    Finally, nonfinancial considerations for life science companies, such as a change in the regulatory landscape or significant FDA action (PDUFA date), are critical in the planning ...
    10-1-2012
  • Candidates' Science Answers Raise More Questions
    ... of the Prescription Drug User Fee Act (PDUFA V), which raises fees for prescription ... PDUFA V includes incentives toward developing antibiotics, while FDA has trumpeted quicker ...
    9-11-2012
  • VC Investors Shun Biotech Startups
    the recently-enacted fifth authorization of the Prescription Drug User Fee Act (PDUFA V). PDUFA V adds five or more years of data exclusivity to the end of patent terms for ...
    7-20-2012
  • Fewer Approvals and Filings Sully FDA Offensive
    ... told GEN. Under PDUFA V, FDA will continue collecting user fees toward new drug reviews. ... PDUFA V and better industry knowledge about FDA's risk-benefit approach should help FDA ...
    7-18-2012
  • Obama Signs FDA Bill Tying User Fees to Reforms
    of the Prescription Drug User Fee Act (PDUFA V), and provisions that expand the ... The FDA Safety and Innovation Act (S.3187) includes PDUFA V among a set of user-fee ...
    7-10-2012
  • FDA Bill Sails Through Senate
    of the Prescription Drug User Fee Act (PDUFA V), as well as provisions that expand the ... The FDA Safety and Innovation Act (S.3187) includes PDUFA V among a set of user-fee ...
    6-27-2012
  • With Oligonucleotide Drugs, Antisense Arrives but RNAi Has a...
    The filing triggers a $25 million milestone payment from Genzyme to Isis. The application has a PDUFA date of January 29, 2013. Kynamro has been evaluated in four Phase III ...
    6-8-2012

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