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California’s proposed prescription drug program will likely undermine future innovations by wrongly imposing artificial price controls, the drug industry says.
A study has found that Celebrex, a pain drug made by Pfizer that belongs to the same class of drugs as the discredited drug Vioxx, may slow or prevent the onset of colon cancer.
Skilled use of outsourcing can save drugmakers money, time and headaches, but it doesn't absolve them of ultimate responsibility for their product and data, a former FDA official said.
The FDA’s plan to fight counterfeiting by tracking drugs through a pedigree system is not likely to accomplish the agency’s goals because of flaws in the federal statute, an expert says.
The U.S. International Trade Commission (ITC) has decided not to review a decision made earlier this year that Roche’s importation and use of its experimental anemia drug Mircera in the U.S. did not violate Amgen’s patents on its anemia drug Epogen. Roche will continue to focus on obtaining FDA approval for Mircera, it said in a Sept. 1 statement.
The FDA’s plan to fight counterfeiting by tracking drugs through a pedigree system is not likely to accomplish the agency’s goals because of flaws in the federal statute, an expert says.
California’s proposed prescription drug program wrongly imposes artificial price controls that could undermine future innovations, the drug industry says.