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The FDA is continuing its initiative to limit unapproved drugs by threatening enforcement actions against manufacturers of unapproved quinine products.
The FDA’s case for implementing its drug-tracking rule just became more difficult as a federal court has seemingly undercut one of the government’s central arguments against a stay on the rule, an industry official says.
Two major pieces of healthcare legislation are closer to becoming law as the Senate was expected to hammer out the final few details late last week before the end of the 109th Congress, sources said.
Pfizer’s sudden decision to end its clinical trials for torcetrapib, a once-likely successor to its blockbuster cholesterol drug Lipitor, not only harms its financial outlook, but also opens the door for other companies to take control of that market, analysts say.
Lawmakers should not interfere with the current off-label prescribing system because doing so would limit patients’ access to the most innovative treatments, a high-ranking FDA official says.
Pfizer’s sudden decision to end its clinical trials for torcetrapib, a once-likely successor to its blockbuster cholesterol drug Lipitor, not only harms its financial outlook, but also opens the door for other companies to take control of that market, analysts say. Read More
Pfizer is predicting a massive increase in the number of new drug products it produces, with as many as four a year being introduced beginning in 2011. Read More