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Sharan Murugan
- Sep 21, 2023
- 1 min
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
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Sharan Murugan
- Sep 20, 2023
- 2 min
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
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Sharan Murugan
- Sep 20, 2023
- 2 min
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...
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Sharan Murugan
- Sep 19, 2023
- 2 min
USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program
Recently (14th September, 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
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Sharan Murugan
- Sep 11, 2023
- 1 min
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
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