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The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practices (CGMP) requirements, and to a research laboratory for failing to comply with good laboratory practices (GLP). The specific issues include concerns about ensuring that final products are sterile and meet specifications, and, in the case of the research laboratory, that the final report adequately details the experience of its animal subjects.

CHARLOTTE, NC — While new approach methodologies (NAM) offer a path to reduced reliance on animal testing, experts say global regulators need to agree on their use to give sponsors predictability and regulatory assurance.

The US Food and Drug Administration (FDA) plans to replace terminology related to animal testing with broader terms, such as “nonclinical tests” and “nonclinical studies” throughout its regulations to facilitate the use of nonanimal methods in drug development.

The European Medicines Agency (EMA) has published a guideline on evaluating drug interactions in the gastrointestinal tract that addresses situations in which extrinsic factors in the gastrointestinal tract may affect drug absorption.

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for active immunotherapy products (ACTIMPs), including cancer vaccines and treatments for autoimmune diseases.

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.

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 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) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug development. The agency is urging companies to adopt new approach methodologies (NAMs), incorporating in vitro human-based systems, such as organs-on-chips and in silico modeling, to assess drug safety.

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.