What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only…
Technical writing, in the context of the therapeutic goods industry, applies to those documents which instruct, define or report on regulated manufacturing activities; that is Standard Operating Procedures, forms, validation reports, and Design History Files, to name so very few and which are also referred to as “controlled documents”. So that these documents can be…
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many of us would like! On the 12th September, I attended the CAPSIG NSW/TGA seminar in Sydney which provided an insight into…
Faecal microbiota transplants are quickly gaining popularity around the world. If you have heard of FMT, chances are either you are not particularly squeamish or you have had enough time to digest the concept, pun intended. To put it mildly, FMT is used to repopulate the bacterial microenvironment in a recipient’s bowel with healthy microorganisms….
The TGA recently announced an update to the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been implemented, taking effect on 30 June 2022. The URTPG: instructs sponsors about how to efficiently and effectively remove marketed therapeutic products that pose a potential risk to users from the distribution chain outlines a consistent approach for undertaking…
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