ALean

Entries by Alanna
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 …

TGA Updates for Medicinal Cannabis

The TGA recently held webinars about reforms that impact the medicinal cannabis industry, including:

Changes to prescribing medicinal cannabis through the Special Access Scheme (SAS) and Authorised Prescriber (AP) pathways
The removal of TGO 93 Standard for Medicinal Cannabis …

GMP Vendor Management Audit Program

Supplying Medicinal Cannabis in Australia

The TGA recently held a webinar called ‘Meeting Your Obligations – Supplying medicinal cannabis in Australia,’ and while it was useful as an overview of the therapeutic good development lifecycle, it did not delve too much into the main …

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 …

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Medicinal Cannabis Stability

As the medical cannabis industry matures, a question has started popping up more frequently regarding medicinal cannabis stability, namely: “What do I put down for shelf life/expiry for a new medicinal cannabis product?”

In this blog we provide a brief …

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S4 CBD for pets and livestock

Given the TGA’s strict supply pathways it would be easy to assume that medicinal cannabis is reserved solely for humans, however, this is not the case. In fact, veterinarians are also able to use certain cannabinoids to treat pets …

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Compliant Medicinal Cannabis Advertising

As many in the pharmaceutical industry know, the TGA has strict rules on advertising therapeutic goods. These rules are outlined via the Therapeutics Goods Advertising Code as well as guidance provided in Australian Regulatory Guidelines for Advertising Therapeutic Goods …

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The Future of CBD

Many heralded the TGA’s proposal to downschedule low-dose cannabidiol (CBD) to S3 as groundbreaking, however, as I’ve covered in a previous blog, there are additional complications that need to be addressed. The TGA’s initial safety review made recommendations for …

FDA Metrics tracker

Updated FDA 483 citations analytics tool

As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have updated their free tool that scrapes data …