Our Articles
Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.
Therapeutic Vaccines – Regulatory Challenges for Non-Clinical Development
Therapeutic vaccines differ from traditional prophylactic vaccines in that they are not targeted to a foreign antigen/protein but instead are intended to modulate the host immune system to endogenously present antigens and are routinely administered after an infection, cancer or other chronic disease state is established.
Scendea announces strategic partnership with CUES Consulting
Scendea is proud to announce our partnership with CUES Consulting, specialists in Japanese regulatory affairs, safety management, and post-marketing surveillance.
FDA 483 - Navigating Compliance Challenges
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.
Expedited Approvals of Medicinal Products
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.
Navigating the Rare Pediatric Disease Priority Review Voucher Program Ahead of September 2024
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.
Transition of Ongoing Clinical Trials in the EU
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.
Australian R&D Cashback & Early Development Activities
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 Achieves a Prestigious King’s Award for Enterprise.
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.
Introduction to EU Regulatory Affairs
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.