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FDA Update: Risk Management and Preventing Drug Shortages
On 20 May 2022, the FDA issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages...
May 31, 2022


VMD and MPI Simultaneous Review – A vision of Cross-border Regulatory Harmony?
On 16 February 2022, The VMD and MPI published a guiding document concerning the simultaneous review of veterinary medicines...
Apr 11, 2022


Australian Business Fined for Alleged Unlawful Advertising of Vaping Products
The Therapeutic Goods Association (TGA) has issued multiple infringement notices to an Australian business amounting to...
Dec 17, 2021


Tomorrow, Today! 3D-Printed Medical Devices at the Point of Care
Historically, the manufacture of 3D-printed medical devices at the point of care (PoC) seemed like science-fiction.
Dec 15, 2021


New TGA Application Form. Medical Device Sponsors, Be Aware!
The Therapeutic Goods Administration (TGA) has indicated a new online form is to be lodged when applying for consent to import...
Dec 10, 2021


Real-World Data and Evidence: The Future in Demonstrating Efficacy?
Regulatory bodies are increasingly considering the expanded usefulness of Real-World Data (RWD) and Real-World Evidence (RWE).
Dec 6, 2021
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