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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awareness information will be subject to FDA rules governing promotional labeling and advertising, the agency said in a draft guidance yesterday.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.
Cost-containment concerns at HHS and an increase in fraud prosecutions by U.S. attorneys are driving a growing investigatory focus on drugmakers’ off-label promotions and their alleged connection to false Medicare and Medicaid claims, according to healthcare and First Amendment legal experts.
The FDA should issue stronger warnings related to the risk of suicide in children who take antidepressants, even as researchers at Columbia University work to clarify the data on the potential risks, an FDA advisory committee recommended yesterday.
The FDA is changing the file-type it accepts for changes to drug labeling from portable document format (PDF) to structured product labeling (SPL) format in order to meet electronic prescribing and health record mandates in the Medicare prescription drug law, the agency said yesterday.
All products from Kos Pharmaceuticals could face more intense scrutiny from the FDA’s Metabolic and Endocrine Drug Products review division following a surprise inspection this summer that revealed a repeat quality control (QC) failure at the firm’s main manufacturing facility.
The FDA has begun a one-year pilot dispute resolution program that will allow drugmakers to formally challenge common scientific and technical issues that may arise during GMP and preapproval inspections.