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Sharan Murugan
- Nov 11, 2023
- 2 min
USFDA Guidance: Real-Time Oncology Review (RTOR)
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023)...
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Sharan Murugan
- Nov 7, 2023
- 1 min
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...
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Sharan Murugan
- Nov 2, 2023
- 1 min
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
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Sharan Murugan
- Oct 31, 2023
- 1 min
TGA Guidance: General Dossier Requirements
Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...
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Sharan Murugan
- Oct 25, 2023
- 1 min
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
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