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Happy Holidays from our Team!
‘Tis the season to take a break.
Dec 7, 2022
Impending Deadline – TGA Pharmacovigilance Risk Assessment Survey
On 17 October 2022, the TGA indicated its Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is open for completion. In...
Oct 27, 2022
Think Ahead, Be Prepared – TGA Post-market Review
Recently, the Therapeutic Goods Administration (TGA) cancelled the registration of four COVID-19 rapid antigen tests...
Aug 11, 2022
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On 20 May 2022, the FDA issued a draft guidance concerning the role of risk management in the prevention of potential drug shortages...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
Huh? Benzene in Sunscreen?
On 28 April 2022, the Therapeutic Goods Administration (TGA) recalled certain batches of six sunscreen products due to benzene contamination
May 6, 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
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
Happy Holidays from Komply!
It's that time of year again!
Dec 3, 2021
Last ACVM Pre-Screen Deadline Approaching
The last Agricultural Compounds and Veterinary Medicines (ACVM) pre-screening application deadline for this year is Friday 03 December 2021.
Nov 29, 2021
TGA Medical Device Reforms
The Therapeutic Goods Association (TGA) will reclassify certain medical devices...
Nov 24, 2021
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