The U.S. government shutdown that began on October 1, 2025, has created uncertainty across multiple sectors — and the biopharmaceutical
Successfully registering a new prescription medicine in Australia requires a deep understanding of the Therapeutic Goods Administration (TGA) approval process.
Part 1 WHAT I’VE LEARNT FROM PREPARING REGULATORY STRATEGIES – BEFORE YOU BEGIN…. So you’ve been asked to prepare a regulatory strategy…
Last week I had the pleasure of chairing a Regulatory Managers panel discussion where we discussed this topic. How many of
Australia’s Therapeutic Goods Administration (TGA) announced earlier this year that Faecal Microbiota Transplant (FMT) would be regulated as biologicALs. Yet,
Introducing a very different type of on-line learning in Regulatory Affairs. Flexible and engaging, tutorial access over six or nine months,