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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.

The European Medicines Agency (EMA) on Monday issued a guideline that sets out the type of information required to develop, manufacture, and control new and existing oligonucleotide drugs.

A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR) poses a challenge for sponsors conducting combined studies of different types of products subject to these regulations. Each regulation has different rules and criteria that apply to clinical research of medical products in the EU, according to a recent study released under the COMBINE initiative.

The European Commission's Medical Device Coordination Group (MDCG) has just released a guidance to assist medical device manufacturers submit the necessary documentation to support clinical investigations that is part of the Investigator's Brochure (IB).

To ensure that the US Food and Drug Administration (FDA) address questions raised by the generic drugmakers through controlled correspondence, sponsors need to ensure that sure that submissions are complete, have a valid letter of authorization, and have valid formulation information.

US Food and Drug Administration (FDA) officials discussed how the generic drug industry can improve the quality of their suitability petitions and avoid rejections as part of the agency's commitment to conduct more timely reviews of these petitions at the Generic Drug Forum sponsored by FDA's Small Business and Industry Assistance (SBIA) Program on 10 April. The meeting was held virtually and on-site in Bethesda, MD.

The US Food and Drug Administration (FDA) has finalized guidance specifying that after 1 April 2026, sponsors will have to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events to FDA's Adverse Event Reporting System (FAERS). Currently, these reports are submitted in electronic common technical document (eCTD) format using PDF files.

Trade groups representing the pharmaceutical and clinical research industries endorsed the US Food and Drug Administration's (FDA) approach for conducting remote interactive evaluations (RIE) as an alternative inspection tool but want more clarity on what FDA will provide at close-out meetings.

Two major pharmaceutical industry groups opposed the US Food and Drug Administration's (FDA) proposal to remove details about interchangeability from product labels in its biologics labeling guidance. They assert that eliminating these statements would create confusion and that these labels are a major source of information for health care providers and prescribers.