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  • Home
  • About
    • About Enimera Regs+
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    • Our Services Overview
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    • TGA New Substance Applications (Listed Medicines) and Listed-Assessed Medicines
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  • GMP LCC Hub
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FDA Shutdown 2025: Impact on Biotech & Pharma Submissions | Enimera RegsPlus
October 13, 2025

The Impact of the 2025 U.S Government Shutdown on FDA Activities: What Biotech and Pharma Need to Know

The U.S. government shutdown that began on October 1, 2025, has created uncertainty across multiple sectors — and the biopharmaceutical

header image of medicine bottle with pills floating out the top
October 17, 2024

Navigating TGA Pathways for Prescription Medicines in Australia: A Brief Overview

Successfully registering a new prescription medicine in Australia requires a deep understanding of the Therapeutic Goods Administration (TGA) approval process.

Biologicals
August 29, 2020

BiologicALs vs Biologics – two letters to FMT

Australia’s Therapeutic Goods Administration (TGA) announced earlier this year that Faecal Microbiota Transplant (FMT) would be regulated as biologicALs. Yet,

Recent Posts

  • The Impact of the 2025 U.S Government Shutdown on FDA Activities: What Biotech and Pharma Need to Know
  • Navigating TGA Pathways for Prescription Medicines in Australia: A Brief Overview
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  • How has the COVID-19 pandemic impacted Regulatory professionals?
  • BiologicALs vs Biologics – two letters to FMT

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