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PDUFA

Latest Headlines

Latest Headlines

Government shutdown would likely roil FDA's drug-approval process

So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."

FDA readies final decisions on four big biotech drugs

The budget cuts required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.

FDA slaps vaginal gel maker for sloppy manufacturing, no NDA

The FDA is again coming down on a California drugmaker for poor-quality manufacturing of an over-the-counter vaginal lubricant for yeast infections that the agency says needs to be treated as a prescription drug anyway.

Pfizer, Bristol-Myers win landmark European approval for Eliquis

The approval comes after the drug developers had been stiff-armed twice by the FDA, which has now set a March 17, 2013 PDUFA date on the therapy.

API maker says more clients looking for U.S. manufacturers

Having had their dalliances with foreign API manufacturers, U.S. drugmakers may be ready to spend more of their money at home.

Industry Voices: PDUFA V Is A Step In The Right Direction

Understanding what's included in the FDA Safety and Innovation Act (FDASIA) and its ramifications for the larger medical products market will be critical to preparing for the implementation of the law in October.

Budget impasse imperils FDA user fee programs

The deficit reduction plan facing Washington lawmakers could derail the FDA's newly approved user fee program slated to provide the agency with $6.4 billion over 5 years, if automatic budget cuts go into effect in January.

FDA pushes back PDUFA date on crucial Pfizer app for tofacitinib

Pfizer put out word this morning that the FDA has opted to delay its application for tofacitinib for three months as it works through some additional analyses the Big Pharma has offered to support its NDA for the rheumatoid arthritis treatment.

FDA has four big drug decisions lined up

The next 5 or 6 weeks look big for potential approvals of new drugs.

FDA calendar crowded with blockbuster decisions for Ironwood, Pfizer and Sanofi

Ironwood's 14-year quest to grow into a full-fledged biotech complete with a commercial product and ambitious development plans is finally coming down to the wire. After posting positive data from a slate of four late-stage studies on the irritable bowel syndrome drug linaclotide, the Cambridge, MA-based developer now faces an early September PDUFA date with the FDA.