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Digital Revolt: Big Data and Veterinary Medicine in the EU
On 13 June 2022, the European Medicines Agency (EMA), unveiled its ‘European Veterinary Big Data Strategy 2022 – 2027’...
Jun 23, 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On 20 May 2022, the FDA issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages...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 31, 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....
May 18, 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
New TGA Consultation: Repurposing Medicines
The Therapeutic Goods Association (TGA) is conducting a public consultation concerning the repurposing of medicines listed...
Mar 23, 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.
Feb 11, 2022
The Future of Clinical Trials in the European Union, and the ‘ACT EU’ Initiative
The European Commission (EC), Heads of Medicines Agencies (HMA), and European Medicines Agency (EMA) recently published their initiative...
Jan 28, 2022
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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