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MHRA Guidance: Registration & Regulating Medical Devices in UK

Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...

Sharan Murugan

Apr 29, 20232 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...

Sharan Murugan

Apr 23, 20231 min read

USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"

Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...

Sharan Murugan

Apr 23, 20231 min read

EMA Guidance: IRIS guide to Registration and Research Product Identifiers

Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...

Sharan Murugan

Apr 23, 20231 min read

Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...

Sharan Murugan

Apr 18, 20231 min read

Swiss Medic: Information sheet on Clinical Investigations with Medical Devices

Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...

Sharan Murugan

Apr 17, 20231 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...

Sharan Murugan

Apr 17, 20232 min read

IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices

Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...

Sharan Murugan

Apr 16, 20232 min read

USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs

Today (12 April 2023) USFDA's Center for Drug Evaluation and Research released two draft guidances on"Assessing Adhesion With Transdermal...

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...

Sharan Murugan

Apr 12, 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...

Sharan Murugan

Apr 11, 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...

Sharan Murugan

Apr 9, 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...

Sharan Murugan

Apr 5, 20231 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...

Sharan Murugan

Apr 5, 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...

Sharan Murugan

Apr 4, 20232 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...

Sharan Murugan

Apr 2, 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...

Sharan Murugan

Mar 31, 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...

Sharan Murugan

Mar 30, 20231 min read

USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems

Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...

Sharan Murugan

Mar 30, 20232 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...

Sharan Murugan

Mar 28, 20231 min read