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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The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug development.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.

The US Food and Drug Administration (FDA) has updated its guidance to cut regulatory burdens on biosimilar manufacturers by reducing the need for conducting pharmacokinetic (PK) studies. The agency said that sponsors may meet their regulatory requirements by submitting analytical data rather than PK studies.

The European Medicines Agency (EMA) has announced that its pilot program for the stepwise pediatric investigation plan (sPIP) has successfully supported timely pediatric development while maintaining scientific rigor. This program will be incorporated into the existing pediatric regulatory landscape.

The US Food and Drug Administration (FDA) has issued guidance for sponsors in reducing testing of single-target monoclonal antibodies in monkeys from six months to three months, or even eliminating such testing altogether.

TGA has adopted about 370 international scientific guidelines as part of Australia's policy of aligning with comparable overseas regulatory counterparts wherever possible. While most of the guidelines in the latest batch would replace those already adopted, two European guidelines are new.

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or subject to a refuse-to-file (RTF) decision, in an updated manual of policies and procedures (MAPP) on Thursday.

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty Makary opened the meeting stating the agency is committed to exploring non-animal models and stressed that reducing animal testing is one of the agency's biggest goals.