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The makers of hormone therapy (HT) products need to revise their labeling to include data from a clinical study that found women over 65 had an increased risk of dementia when taking oral conjugated estrogens plus medroxyprogesterone acetate, the FDA said last week.
A health advocacy group is demanding that the FDA remove three members of its Psychopharmacologic Advisory Committee who had done research, consulting and other work for manufacturers of antidepressant drugs, even though the committee recently urged the agency to issue stronger warnings about increased suicide risk among children taking those drugs.
An FDA mandate requiring companies to switch to a new file format when submitting drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, according to some industry experts.
Switching to a new file format required by the FDA to submit drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, some industry experts say.
Beginning next year, drug companies will have to alter the way they submit changes to drug labeling, switching from portable document format (PDF) to the structured product labeling (SPL) format in order to meet electronic prescribing and health record mandates in the Medicare prescription drug law, the FDA said last week.
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.
Drug manufacturers could cut their costs for advertising and better educate consumers at the same time, if they follow the guidelines in one of two draft guidances on direct-to-consumer (DTC) advertising released by the FDA last week, agency officials said.
Drugmakers’ general disease awareness communications must be perceptually distinct from promotions of specific drugs or the awareness information will be subject to FDA rules governing promotional labeling and advertising, the agency said in a draft guidance yesterday.
Drug manufacturers may be able to cut advertising costs -- and better educate consumers -- if they adopt recommendations contained in one of two draft guidances on direct-to-consumer advertising released by the FDA yesterday, agency officials said.
Despite a statement from four prominent medical associations warning about the risk of adverse side effects of some antipsychotics, Pfizer continues to resist FDA-requested labeling changes for its Geodon (ziprasidone HCl) product.