Cosmetic FDA Regulations (MoCRA)
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Cosmetic FDA Regulations (MoCRA)

New FDA regulations for cosmetic products: Updates to the US Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 USC 364 (FDA Cosmetic Regulations). MoCRA: FDA cosmetic manufacturing regulations MoCRA: Effective date for FDA Cosmetic Regulations Most of the provisions in MoCRA take effect at the close of 2023. These include mandatory facility…

Psilocybin and MDMA move into mainstream medicine

Psilocybin and MDMA move into mainstream medicine

It might seem that changes to pharmaceutical regulations move at a glacial speed but, be assured, that they do move and they are happening. Back in August 2020 (you remember that year – you made a LOT of sourdough), Australia’s Therapeutic Goods Administration (the TGA) announced a consultation regarding amendments to the Poisons Standard. Amongst…

Number of Medicinal cannabis Prescriptions and Prescribers in Australia
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Number of Medicinal cannabis Prescriptions and Prescribers in Australia

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 is a science, not an art
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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 few and which are also referred to as “controlled documents”. So that these documents can be…