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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.

The US Food and Drug Administration has issued another untitled letter to Novo Nordisk for airing a TV ad for one of its glucagon-like peptide-1 (GLP-1) receptor agonist drugs. The agency said the Ozempic (semaglutide) ad misleads customers about who is eligible to take the injections.

The US Food and Drug Administration's (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the current 10-digit code, with a uniform, 12-digit format.

Pharmaceutical industry groups, drugmakers, and other industry stakeholders are pressuring the US Food and Drug Administration (FDA) to finalize its proposed rule to update the format of the National Drug Code (NDC) by the end of March 2026.

The US Food and Drug Administration (FDA) recently cited Johnson & Johnson subsidiary Janssen and Sobi for airing direct-to-consumer (DTC) television ads that failed to sufficiently disclose the risks associated with their drugs and for making claims that overstate the drugs' benefits.

The US Food and Drug Administration (FDA) announced on Thursday that it has approved updates to the labeling of six hormone replacement therapy (HRT) products used to treat menopause. These updates include the removal of boxed warnings concerning cardiovascular diseases, breast cancer, and probable dementia associated with the use of these therapies.

The US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued its first two untitled letters of the year to two companies, Altor BioScience and BeOne Medicines alleging that the companies made false or misleading claims on their websites or in TV advertisements. The companies have been given 15 days to respond to the letters.