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 …
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 …
Every year, the Therapeutic Goods Administration (TGA) undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the TGA fees and charges being proposed for the upcoming financial year, including TGA application fees for …
During a webinar last year, the TGA announced they were intending to introduce changes to the medicinal cannabis regulations (including supplier assurance requirements for imported medicinal cannabis products). In light of that, a TGA consultation on potential reforms to …
After Mind Medicine’s very successful International Summit on Psychedelic Therapies for Mental Illness, I’m sure the nascent industry is ablaze with ideas and inspiration.
The down-scheduling decision on MDMA and psilocybin is due to be released in Dec 2021, and …
Glancing at headlines these days there appears to be a consistent stream of positive news breaking out all over the world about the potential therapeutic benefits of psychedelics, including a declaration from the FDA that psilocybin is a “breakthrough …
What is a Unique Device Identifier (UDI)?
Unique Device Identifier (UDI) is a globally unique series of characters for each medical device on the market to:
Unambiguously identify a device for patient safety
Improve medical device traceability in the supply chains
The Unique …
Have you ever come away from an audit feeling unsure of your own organisational processes? Do you sometimes feel that your organisation is alone or unique in the types of audit deficiencies observed? How do you compare with others …
Industry support of overdose prevention
This is blog 8 of 10 Blogs in the overdose awareness and overdose prevention series.
What is GxP compliance? And how does GMP/GxP compliance help with overdose prevention efforts?
GMP and GxP are pharmaceutical-industry quality standards and …
Snapshot of the Opioid Crisis (Legal Cases)
This is blog 6 of 10 blogs in the overdose awareness and overdose prevention series.
International Overdose Awareness Day (31st August) is rapidly approaching. It warrants a discussion of the opioid crisis in the …
