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The FDA is not giving up the drug importation fight, despite a growing demand for what still are illegally imported prescription drugs and the abetting of such importation by a growing number of state and local governments.
Mylan Pharmaceuticals is arguing in a lawsuit that the FDA has disregarded its own precedent that authorized generics are functionally and legally equivalent to true generics by allowing a brand-authorized generic to launch during Mylan’s generic marketing exclusivity period.
HHS and the FDA said they would “vigorously” defend themselves against allegations that the agencies are not acting quickly enough to establish a program that would allow the legal importation of prescription drugs from Canada.
Dietary supplement ephedra manufacturers have asked a U.S. District Court to invalidate the FDA rule banning the substance and to enjoin the FDA from enforcement action against the plaintiffs for the continued sale of ephedra in low doses.
A clinical research group says that to reduce costs and delays in the drug development process, the FDA should consider fundamentally redesigning the current clinical trial model, including allowing investigational drugs to go to market on a conditional basis.
There is some evidence to suggest an increased risk of suicidal behavior for children using certain antidepressant medications, the FDA said in a statement that at least partially vindicates findings made by FDA scientist Andrew Mosholder months ago.
An FDA-funded study of Merck arthritis drug Vioxx found that the popular drug may increase the risk of serious heart problems, but the company disputed the report’s findings as inconsistent with results from clinical trials.
The FDA has issued warning letters to two pharmaceutical companies, one for issuing misleading promotional materials and the other for violating current good manufacturing practices (cGMP).
To reduce costs and delays in the drug development process, the FDA should consider fundamentally redesigning the current clinical trial model, including allowing investigational drugs to go to market on a conditional basis, according to a clinical research group.
The Centers for Medicare & Medicaid Services (CMS) may soon begin covering routine costs of Category A clinical device trials in a move to promote emerging technologies.