The U.S. government shutdown that began on October 1, 2025, has created uncertainty across multiple sectors — and the biopharmaceutical industry is no exception. For the U.S. Food and Drug Administration (FDA), the impact is complex, reflecting both the agency’s critical public health mission and its reliance on User Fee Act
Successfully registering a new prescription medicine in Australia requires a deep understanding of the Therapeutic Goods Administration (TGA) approval process. Whether you are bringing a novel treatment to market or submitting a generic version of an existing therapy, choosing the right pathway is essential. Below is a streamlined overview of
Part 1 WHAT I’VE LEARNT FROM PREPARING REGULATORY STRATEGIES – BEFORE YOU BEGIN…. So you’ve been asked to prepare a regulatory strategy… good for you! You’ve been given an opportunity to contribute at a higher level and demonstrate how you bridge your technical expertise with your organisation’s drivers. Though consider yourself warned
Last week I had the pleasure of chairing a Regulatory Managers panel discussion where we discussed this topic. How many of these key messages resonate with you? The U in VUCA– be comfortable with a level of Uncertainty as Uncertainty is unavoidable – in fact, one can even say it is
Australia’s Therapeutic Goods Administration (TGA) announced earlier this year that Faecal Microbiota Transplant (FMT) would be regulated as biologicALs. Yet, many biologically-derived medicines are regulated as what we tend to call biologics. So how do two letters distinguish between two regulatory pathways, and how to remember the difference? BiologicALs vs Biologics - two letters
Introducing a very different type of on-line learning in Regulatory Affairs. Flexible and engaging, tutorial access over six or nine months, and with the option to complement the learning with mentoring and a Certificate of Completion.