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Including race and ethnicity data on FDA MedWatch forms could hinder companies’ postmarket adverse event reporting efforts and be of little scientific value, according to comments recently submitted to the agency.
Drugmakers will have to affix linear bar codes to the labels of most of their prescription drug products under a new FDA regulation expected to cost the industry $28.1 million in the first two years of implementation, but projected to save the healthcare system billions of dollars in prevented medication errors.
Eli Lilly has warned doctors and psychiatrists that using its antipsychotic drug Zyprexa (olanzapine) to treat elderly patients with dementia can increase their risk of stroke and death.
Adding race and ethnicity reporting requirements to FDA MedWatch forms is liable to impede companies’ postmarket adverse event reporting efforts and be of little scientific value, according to comments recently submitted to the agency.
A federal appeals court has refused to reinstate a wrongful death lawsuit against Pfizer brought by the parents of a child who killed himself after six days of taking the company’s antidepressant Zoloft (sertraline HCl).
The FDA has issued a warning letter to Xttrium Laboratories for failing to correct problems with its postmarketing adverse drug experience (PADE) reporting system for chlorhexidine gluconate products.
The U.K.'s Medicines and Healthcare products Agency (MHRA) is urging the country's healthcare providers and other healthcare practitioners to stop using devices for purposes other than that those explicitly stated by the original devicemaker's labeling or instructions for use.
The leader of a key subcommittee in the U.S. House of Representatives is investigating allegations that drugmakers have suppressed clinical trial data that shows increased risk of suicide in children who are treated with antidepressants.
FDA officials contend the data they have on a possible link between antidepressant use in children and an elevated risk of suicide are still too ill-defined to reach any conclusions, even though an advisory committee has recommended the agency issue stronger warnings.