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The FDA does not do a good enough job in making drug development information available to the public, and proposals for clinical-trial registries do not go far enough to address this problem, the activist group Public Citizen said in a study published in the Duke Law Journal.
Senate Majority Leader Bill Frist (R-Tenn.) plans to use a recent Congressional Budget Office (CBO) report on drug industry R&D to get additional federal funding for comparative drug trials, a congressional source says.
The call by five current and former members of the FDA’s Drug Safety and Risk Management Advisory Committee for Congress to improve the agency’s drug safety system, with recommendations such as an independent drug safety office, is being dismissed by some in industry as nothing new.
Limited importation of prescription drugs from Canada became law Oct. 4 as President Bush signed legislation legalizing it, but a policy reversal by a federal agency could lead to even broader use of the practice.
The fact that the newest generation of antipsychotic drugs used to treat schizophrenia is no more effective than earlier, less expensive treatments illustrates the need for a national dialogue about comparative effectiveness between drug classes, an academic says.
Gilead Sciences is seeking to beef up its drug pipeline and its emphasis on treatments for pulmonary conditions, announcing Oct. 2 it will acquire Myogen for $2.5 billion.
Barr Pharmaceutical announced Sept. 28 that it is now free to close a deal with Shire, acquiring the rights to Shire’s attention-deficit/hyperactivity disorder drug Adderall immediate-release (IR) tablets.
Activists will seek permission in federal court this month to gain access to White House documents and to depose a former administration adviser concerning the controversial contraceptive Plan B to determine whether the White House interfered in the FDA’s decisionmaking on the drug.