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Sharan Murugan
May 4, 20231 min read
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
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Sharan Murugan
May 4, 20231 min read
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...
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Sharan Murugan
May 2, 20232 min read
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...
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Sharan Murugan
Apr 29, 20232 min read
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
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Sharan Murugan
Apr 23, 20231 min read
Health Canada: Guidance on Nitrosamine Impurities in Medications
Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...
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Sharan Murugan
Apr 17, 20232 min read
Ireland's HPRA: Guide to SAR /Event Reporting for Human Organs Intended for Transplantation
Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse...
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Sharan Murugan
Apr 11, 20231 min read
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...
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Sharan Murugan
Apr 9, 20231 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...
175 views0 comments
Sharan Murugan
Apr 5, 20231 min read
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
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Sharan Murugan
Apr 5, 20232 min read
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...
63 views0 comments
Sharan Murugan
Apr 4, 20232 min read
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...
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Sharan Murugan
Apr 2, 20231 min read
Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...
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Sharan Murugan
Mar 31, 20231 min read
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...
67 views0 comments
Sharan Murugan
Mar 30, 20231 min read
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
57 views0 comments
Sharan Murugan
Mar 28, 20231 min read
Pakistan's DRAP: Guidelines for Good Cold Chain Management Practices
Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for...
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Sharan Murugan
Mar 24, 20231 min read
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...
25 views0 comments
Sharan Murugan
Mar 20, 20231 min read
Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...
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Sharan Murugan
Mar 17, 20231 min read
Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...
161 views0 comments
Sharan Murugan
Mar 17, 20231 min read
USFDA Guidance: Pharmacogenomic Data Submissions
Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics...
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Sharan Murugan
Mar 16, 20231 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
29 views0 comments