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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.

A panel convened by the US Food and Drug Administration (FDA) on Thursday recommended easing restrictions on testosterone replacement therapy (TRT) for men. Currently, FDA labeling states that this drug should only be used if a man has low testosterone due to a specific medical condition, such as hypogonadism. The panel also suggested removing the classification of these therapies as controlled substances, arguing that the current restrictions are compromising men's health.

The US Food and Drug Administration (FDA) has finalized guidance on promotional labeling and advertising for prescription biosimilars, interchangeable biosimilar products, and their reference listed drugs (RLDs) to ensure that such labeling is accurate and truthful.

Washington, DC – Experts said that the US Food and Drug Administration (FDA) should provide more clarity on how it intends to regulate the use of artificial intelligence and large language models when they are used in the development or manufacture of a product but are not part of the product itself.

Pharmaceutical industry stakeholders suggested some modifications to the US Food and Drug Administration's (FDA) recently released draft clinical outcome assessments (COA) template for ensuring that treatments are patient-centric and support effective regulatory decision-making.

The US Food and Drug Administration (FDA) on Monday announced its plan to remove the boxed warnings for menopausal hormone therapies (MHT), commonly referred to as hormone replacement therapy (HRT), following the recommendation of an expert panel convened by the agency in July.