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Pfizer calls on FDA to deny a recent Purdue Pharma petition asking that Pfizer be required to reference a Purdue drug in its appli...[ Price : $8.95]
Omthera says a federal court decision in the Amarin case supports its argument that its Epanova is entitled to five-year new chemi...[ Price : $8.95]
FDA clears a Reflexion Health 510(k) for its motion-tracking physical therapy tool, Vera.[ Price : $8.95]
CDRH says Production and Process Controls and Corrective and Preventive Actions continue to be the most frequently cited Quality S...[ Price : $8.95]
Attorneys Raymond Bonner and William McConagha predict a busy FDA enforcement schedule in the next three to five years, especially...[ Price : $8.95]
In the face of stiffening opposition from Public Citizen, among others, a letter addressed to Senate leaders by 50 patient and hea...[ Price : $8.95]
A new report finds that the U.S. health care system saved a record $254 billion in 2014 from generic drugs.[ Price : $8.95]
A Tufts Center for the Study of Drug Development analysis shows that marketing exclusivity often goes to the company that can shor...