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A study showing that patients taking Gleevec could be at increased risk for certain cardiovascular problems has resulted in Novartis changing the labeling for the blockbuster cancer drug.
Baxter should change the labels on two heparin products to clearly differentiate the version used to treat adults from the one used to treat premature infants, but a broader solution would be to implement a label universal to all products routinely used in infants, according to a lawyer representing families of two babies that died after receiving the wrong dosage of the drug.
Health Canada is revising the prescribing and patient information for attention-deficit/hyperactivity disorder (ADHD) drugs to include data about the potential risk for adverse psychiatric events, including rare instances of agitation and hallucinations in children.
The FDA needs to develop regulations to establish a more consistent off-label enforcement policy, as law enforcement currently has too much influence, an industry attorney said.
The FDA will revise the warning portion of birth control patch Ortho Evra’s label to incorporate two epidemiology studies sponsored by Johnson & Johnson (J&J), the agency announced Sept. 20.
The FDA announced Sept. 20 that the results of two epidemiology studies sponsored by Johnson & Johnson (J&J) will be added to the warning portion of the label for the birth control patch Ortho Evra.
Law enforcement currently takes too prominent of a role in setting off-label enforcement policy, necessitating regulations to establish more consistent policy, an industry attorney said.
A federal court is considering a case that could render the FDA’s current labeling enforcement strategy unworkable and dramatically increase companies’ potential liability, current and former agency chief counsels said.
The HHS Office of Inspector General (OIG) is leading the federal government’s effort to limit off-label drug promotion — a move that will hurt public health protection and may violate the First Amendment, industry attorneys say.