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Sharan Murugan
Nov 30, 20231 min read
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...
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Sharan Murugan
Apr 12, 20231 min read
USFDA Guidance: Format and Content for OTC Monograph Order Requests
Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...
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Sharan Murugan
Sep 8, 20222 min read
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...
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