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Sharan Murugan
- Jan 4, 2023
- 1 min
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide
The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...
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Sharan Murugan
- Nov 12, 2022
- 1 min
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...
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Sharan Murugan
- Nov 4, 2022
- 1 min
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...
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Sharan Murugan
- Nov 1, 2022
- 1 min
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
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Sharan Murugan
- Nov 1, 2022
- 1 min
USFDA Guidance: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Earlier today (1-November-2022) the USFDA finalized and released "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based...
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