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May 31, 2022
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On 20 May 2022, the FDA issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages...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 18, 2022
TGA Follows FDA - COVID-19 Treatment Use Expanded
On 6 May 2022, the Therapeutic Goods Administration (TGA) provisionally approved the expanded use of Veklury (remdesivir) in Australia....
Feb 11, 2022
FDA Policy Update: COVID-19-related Sanitation Tunnels
The FDA has expressed concern surrounding the safety and efficacy of sanitation tunnels developed to combat the spread of COVID-19.
Dec 15, 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 6, 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).
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