Scendea is proud to announce our partnership with CUES Consulting, specialists in Japanese regulatory affairs, safety management, and post-marketing surveillance.

An FDA 483, also known as a “Form FDA 483” is a document issued by the U.S. Food and Drug Administration (FDA) to a company at the conclusion of an inspection, when the FDA investigator has observed any conditions that in their judgement may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts. 

Developing a novel drug, including discovery, nonclinical toxicology studies, and clinical studies, may take many years. Once a Company has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorisation application. 

The rare pediatric disease priority review voucher (RPD PRV) program was introduced by the US Food and Drug Administration (FDA) in 2012 with the aim of incentivizing drug development for new medicines targeting rare pediatric diseases.

In the evolving landscape of clinical research and regulatory frameworks, Regulation 536/2014, also referred to here as the Clinical Trials Regulation (CTR), marks a significant milestone set to transform the conduct and oversight of clinical trials.

With demand for improved healthcare increasing globally, Australia is continuing to emerge as an attractive destination for the development of new and improved drugs and medical devices, driven by excellent research capabilities, a favourable Therapeutic Goods Administration (TGA) regime and an attractive Research and Development Tax Incentive (RDTI) regime.

Scendea Ltd is proud to announce it has received a King’s Award for Enterprise for International Trade 2024. This prestigious award recognises Scendea’s outstanding growth in international trade.

In the European Union (EU) a network of approximately 50 regulatory authorities from the 30 European Economic Area (EEA) countries1, the European Commission (EC) and European Medicines Agency (EMA) form the basis of the European regulatory system and play a role in the authorisation and monitoring of medicines in this region.

Sponsors of investigational medicinal products (IMP) are encouraged to seek guidance from the FDA throughout the course of development in order to maximise the likelihood of regulatory approval. The FDA offers opportunities for Sponsors to request guidance on a development program free of charge and irrespective of the stage of development.