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![USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product](https://static.wixstatic.com/media/nsplsh_14c18afa532042bb96d4ed9c20c0dec1~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_14c18afa532042bb96d4ed9c20c0dec1~mv2.jpg)
Sharan Murugan
- Jun 22
- 2 min
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...
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![USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission](https://static.wixstatic.com/media/nsplsh_f9f4a8298e5e447998f00764a7795e79~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f9f4a8298e5e447998f00764a7795e79~mv2.jpg)
Sharan Murugan
- Jun 9
- 2 min
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...
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![USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers](https://static.wixstatic.com/media/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_f2895b9f7aea4be79b1b1833a2bcb049~mv2.jpg)
Sharan Murugan
- Jan 28
- 2 min
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
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![USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities](https://static.wixstatic.com/media/nsplsh_77410cb184ba46759e7189f9547de3cb~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_77410cb184ba46759e7189f9547de3cb~mv2.jpg)
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Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
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![Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System](https://static.wixstatic.com/media/nsplsh_2669401970f44e18ac16ed547ff9571d~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_2669401970f44e18ac16ed547ff9571d~mv2.jpg)
Sharan Murugan
- Jul 21, 2023
- 2 min
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
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