TGA

Technical-writing-is-a-science-not-an-art

Technical writing is a science, not an art

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 …

TGA-fees-TGA-application-charges-2022

Latest TGA fees and charges – updated 1 July 2022

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 …

PharmOut Innovation Dinner

Psychedelic Therapies in Australia – the next steps forward

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 …

GMP-documentation

Australian Regulatory Framework Psychedelic Therapies

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 …

GxP What-is-GxP-acronym-definition

What is GxP compliance?

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 …

egal-cases-opioid-crisis-settlements.

Opioid Crisis (Legal Cases)

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 …