ALean

Entries by Alanna
Young-doctor-offering-pill

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 …

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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 …

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 …

PIC/S GMPs vs WHO GMPs – what’s the difference?

As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry.

Those who fall under the umbrella of …

Hands with cream

CBD cosmetics – a cautionary tale

Unlike other markets (i.e. Canada, the US, the UK and parts of Europe) CBD is more strictly controlled in Australia, and the pure extracts (as well as any associated products) are considered Schedule 4 …