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The US Food and Drug Administration (FDA) has notified more than 2,200 medical product manufacturers and researchers to disclose clinical trial results as required by law. The agency said it is part of its risk-based efforts to encourage relevant parties to act before it potentially decides to take regulatory action.

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial intelligence (AI)-enabled medical devices throughout their product life cycle.

The International Council on Harmonization (ICH) E22 guideline should incorporate caregiver feedback, according to responses submitted by industry groups and manufacturers to a US Food and Drug Administration public consultation.

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

US Food and Drug Administration (FDA) officials credited recent advancements in regulatory science and flexibilities with enabling growth in the cell and gene therapy sector during a meeting on Thursday; however, a cell therapy expert said there is still reluctance from FDA and industry to enroll pediatric patients in clinical trials for such treatments.

The US Food and Drug Administration (FDA) has issued a warning letter to a medical spa company in Texas for violating the Drug Supply Chain Security Act (DSCSA) after finding the firm dispensed “significantly more” units of AbbVie’s Botox (onabotulinumtoxinA) than it purchased through legitimate channels.

In the latest meeting minutes released by the US Food and Drug Administration (FDA), the agency noted that significant progress has been made toward an agreement with the pharmaceutical industry for the next Pharmaceutical Drug User Fee Amendments (PDUFA VIII) commitment language.

The US Food and Drug Administration (FDA) has submitted its budget proposal to Congress, outlining its spending priorities for fiscal year 2027. The budget request totals $7.2 billion, including $3.3 billion in appropriations and $3.9 billion in user fees. This request represents an overall increase of approximately $232 million, or 3.3%, compared to the fiscal year 2026 level.

In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after drugmakers for marketing glucagon-like peptide-1 (GLP-1) receptor agonists and similar medications without regulatory approval. It also issued other warning letters for current good manufacturing practices (CGMP) violations and failing to adhere to clinical trial protocols.

The US Food and Drug Administration (FDA) has announced that starting on 1 October 2026, manufacturers must submit adverse event individual case safety reports (ICSRs) for drugs, biologics, and combination products using the data standards specified in the International Council for Harmonisation’s (ICH) E2B(R3) guideline.

Several patient and disease advocacy organizations have responded to the Center for Drug Evaluation and Research's (CDER) request for feedback on what it should provide as part of its Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) educational materials.

Stakeholders responding to recent draft guidance from the US Food and Drug Administration (FDA) on the use of minimal residual disease (MRD) and complete response (CR) primary endpoints for multiple myeloma accelerated approval products say they want more examples of appropriate use of these endpoints, and for the agency to consider expanding the draft guidance to drugs and biologics for other hematologic malignancies.

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, while other topics, such as drug master files (DMFs) and forfeiture determinations are still being discussed.

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for violations of current good manufacturing practices (CGMP). Additionally, regulators said the medical device maker has been selling products without marketing authorization, despite the company arguing that its products should be considered pre-amendment devices and therefore not regulated by the agency.

Two former US Food and Drug Administration (FDA) officials have commented on and proposed changes to the agency’s recent draft guidance on the development of a plausible mechanism framework for individualized therapies to treat rare diseases.

Stakeholders are being encouraged to weigh in on the European Chemicals Agency (ECHA) 60-day public consultation period related to a planned ban on per-and-polyfluoroalkyl (PFAS) substances, also known as forever chemicals.

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.

The European Medicines Agency (EMA) has finalized a document with recommendations on using the European Medicines Regulatory Network (EMRN) Data Quality Framework (DQF) when submitting premarket applications that include real-world data.

The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the total product life cycle.

The US Food and Drug Administration (FDA) has warned an oncology drug company for repeatedly overstating the efficacy of its drug in advertisements while failing to adequately disclose the associated risks. The agency also issued several warning letters to companies for violations of current good manufacturing practices (CGMP) and for marketing products for non-approved indications.