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Sharan Murugan
- Sep 1, 2022
- 1 min
Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation
The Singapore Health Sciences Authority (HSA) published a Safety Alert for Finasteride on 30-August-2022. Suicidal ideation is a known...
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Sharan Murugan
- Sep 1, 2022
- 1 min
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...
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Sharan Murugan
- Aug 30, 2022
- 1 min
Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities
Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...
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Sharan Murugan
- Aug 30, 2022
- 1 min
SFDA Guide to Good Manufacturing Practice for Medicinal Products
On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...
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Sharan Murugan
- Aug 27, 2022
- 2 min
ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation
In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...
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