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The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug development.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

Swissmedic has started a pilot project to evaluate the faster processing of certain clinical trial applications.

The US Food and Drug Administration (FDA) is loosening its requirement for animal testing of monoclonal antibodies (mAbs) and other drugs, the agency said in an announcement.

LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure that devices work as intended without compromising safety and effectiveness, according to two experts speaking at the RAPS Global Regulatory Strategy Conference on Tuesday.

The US Food and Drug Administration (FDA) on Monday published a letter to Chinese medical device testing firm Mid-Link Technology Testing advising the company that all data from its studies will be rejected until the company can adequately address its issues.

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.

The European Medicines Agency (EMA) has recently adopted a guideline outlining the quality, non-clinical, and clinical requirements to support a clinical trial application for investigational advanced therapy medicinal products (ATMPs).

Stakeholders want more discussions on the kinds of data that can be used when stakeholders consider using model-informed drug development (MIDD) approaches. They note that there is uncertainty about what kinds of data the US Food and Drug Administration (FDA) will accept when such models are employed.

San Diego – Cell and gene therapy (CGT) manufacturers should take advantage of the numerous pathways available and meet with the US Food and Drug Administration early to iron out any questions they have during product development, Najat Bouchkouj advised at the DIA Global Annual Meeting.

The European Medicines Agency (EMA) is seeking feedback on non-interventional studies (NIS) that use real-world data (RWD) for regulatory purposes.

The European Medicines Agency (EMA) said in a new reflection paper that it will consider granting conditional marketing approval to sponsors developing treatments for non-alcoholic steatohepatitis (NASH) based on the use of intermediate endpoints to address a high unmet need for these products.