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Sharan Murugan
Apr 72 min read
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a...
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Sharan Murugan
Mar 302 min read
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
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Sharan Murugan
Jan 182 min read
MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...
73 views0 comments
Sharan Murugan
Jan 131 min read
EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...
84 views0 comments
Sharan Murugan
Dec 27, 20232 min read
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
Earlier this week the the U.S. Food and Drug Administration (FDA) released multiple guidances that is related to Digital Technologies and...
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Sharan Murugan
Aug 4, 20221 min read
Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes
Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...
216 views0 comments