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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) 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.

The European Medicines Agency (EMA) has released a revised draft reflection paper that outlines non-animal replacement tests manufacturers can use to eliminate the use of animals in pharmaceutical testing.

NORTH BETHESDA, MD – Regulators around the globe are making progress in implementing the Identification of Medicinal Products (IDMP) a global set of standards for identifying medicinal products. The EU is at the forefront of these efforts, while other countries, including Switzerland and Canada, are in the early stages of adopting IDMP standards. An EMA official said that mapping their identification data to the IDMP standards has 'not been easy.”

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) on Wednesday announced a revised guidance aimed at creating a consistent approach for identifying commercially confidential information (CCI) and personal data (PD) in marketing authorization applications (MAAs) for human medicines.

A working group from the International Council for Harmonisation (ICH) is evaluating the establishment of a global, secure technology platform for regulators. This platform would facilitate the joint review of post-approval changes in chemistry, manufacturing, and controls (CMC) that the industry requests for currently marketed drug products.

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last Friday announced that effective next October 2025, medical device manufacturers will have to use the electronic Submission Resource and Resource (eSTAR) template for submitting de novo applications.

The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities' (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority.