Industry and other stakeholders want the US Food and Drug Administration (FDA) to provide more clarity and ensure flexibility in a revised guidance on how drug and medical device makers should communicate with payors and other stakeholders about their products.
The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.
The US Food and Drug Administration’s (FDA) plans to eliminate adequate provision in direct-to-consumer (DTC) prescription drug ads could result in a de facto ban on drug advertising due to the high costs associated with fully publicizing a drug's safety profile and practical limitations of broadcast advertising, according to experts who spoke to Focus. It could also make such ads hard to understand for many consumers.
The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to issue in 2026, including 22 final and 43 proposed rules by the US Food and Drug Administration (FDA).
The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to QOL Medical to “false or misleading” claims made in promotional emails for its congenital sucrase-isomaltase deficiency (CSID) treatment Sucraid (sacrosidase) oral solution.
The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has stepped up its enforcement efforts regarding prescription drug promotion, issuing three new untitled letters to Pfizer Inc., Amneal Pharmaceuticals LLC, and BioCorRx Pharmaceuticals Inc.
The European Medicines Agency (EMA) has finalized updated guidance on the information required for the manufacture and control of active substances used in medicinal products, with a 1 September date of application.
The US Food and Drug Administration (FDA) on Thursday finalized guidance to assist sponsors developing medical devices intended for weight loss at the premarket stage. This guidance provides information on non-clinical testing, clinical study design for these submissions, and outlines how the agency evaluates the benefit-risk analysis needed to support weight loss claims.
BALTIMORE – Without guidance from the US Food and Drug Administration (FDA), experts said that companies must develop their own best practices for using artificial intelligence (AI) for pharmaceutical advertising and promotional activities, including creating web, social media, broadcast, or print content.
