News & Insights Search

The European Medicines Agency (EMA) has launched a voluntary data submission (VDS) pilot to allow drug developers to share data generated by new approach methodologies (NAM), which regulators say may help reduce the need for traditional animal studies during drug development. The announcement follows other efforts by global regulators to reduce reliance on animal testing.

Sponsors who want to use digitally derived endpoints from digital health technologies (DHT) should validate those endpoints for the intended patient population, pre-specify their missing-data strategy at every level of their clinical trial, and avoid conflating device clearance with endpoint validation, according to US Food and Drug Administration (FDA) officials who spoke at a recent public meeting.

The US Food and Drug Administration (FDA) has published a draft guidance on how to design trials and analyze data from studies examining the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs in patients with hepatic impairment (HI). The agency noted that impaired liver function can have a significant impact on how drugs are absorbed and filtered, requiring a better understanding of their effects.

The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervous system (CNS) toxicity through non-clinical safety assessments, according to a recent paper proposing a new safety framework for predicting neurological risk in CNS drug development.

The US Food and Drug Administration (FDA) is seeking stakeholder feedback to create a Quantitative Medicine Innovation Network (QMIN), a cross-sector platform that uses quantitative medicine approaches to accelerate drug development and regulatory science and improve clinical decision-making.

The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS products and a draft guidance on assessing skin irritation using in vivo studies in TDS products.

Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than accelerated approvals, according to a study published in JAMA on Thursday.

The US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has finalized a trio of guidance documents to promote greater participation and diversity in oncology clinical trials. The documents address three areas: a patient’s performance status, laboratory values, and washout periods.

Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.

Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the time of approval. Of those, the vast majority of study results were published in ClinicalTrials.gov or another publication, according to an article published Thursday in JAMA Network Open.