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Sharan Murugan
Nov 9, 20242 min read
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
The Study Data Technical Conformance Guide (SDTCG)Â from the USFDA provides a framework to help sponsors submit standardized study data...
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Sharan Murugan
Nov 3, 20242 min read
SwissMedic Med Dev: Clinical Investigations of Medical Devices & Performance Studies of In Vitro Diagnostics (IVD)
The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...
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Sharan Murugan
Nov 3, 20242 min read
Australia's TGA Good Clinical Practice (GCP) Inspection Program
Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...
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Sharan Murugan
Nov 1, 20242 min read
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Recently 30th October, 2025 the U.S. Food and Drug Administration (FDA) issued guidance titled " M13A: Bioequivalence for...
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Sharan Murugan
Nov 1, 20242 min read
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...
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Sharan Murugan
Oct 27, 20242 min read
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...
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Sharan Murugan
Oct 27, 20242 min read
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
Recntly Switzerland's Swissmedic provided essential information on guidance " Fast-Track Authorisation Procedure "Â and " Temporary...
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Sharan Murugan
Oct 27, 20242 min read
MDCG Guidance: MDR requirements for Legacy Devices
The Medical Device Coordination Group (MDCG) has released guidance " Application of MDR requirements to ‘legacy devices’ and to devices...
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Sharan Murugan
Oct 22, 20242 min read
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
The US FDAÂ released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...
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Sharan Murugan
Oct 22, 20242 min read
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...
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Sharan Murugan
Oct 22, 20242 min read
UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
On 18th October, 2024 the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their guidance on the processes related...
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Sharan Murugan
Oct 17, 20242 min read
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024)Â has issued two comprehensive Q&A guidance titled " Core...
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Sharan Murugan
Oct 17, 20242 min read
USFDA Guidance: Review of Drug Master Files in Advance of Certain ANDA Submissions
U.S. Food and Drug Administration announced yesterday (17 October 2024) a final guidance , " Review of Drug Master Files in Advance of...
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Sharan Murugan
Oct 14, 20242 min read
MDCG Med Dev: Guidance and Templates for Conformity Assessment Bodies, Notified Bodies, Designating Authorities, and Joint Assessment Teams
The Medical Device Coordination Group (MDCG) Â has released its updated guidance and templates for conformity assessment bodies, notified...
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Sharan Murugan
Oct 14, 20242 min read
MDCG Med. Dev Guidance: Qualification of In Vitro Diagnostic Medical Devices (IVDs)
The Medical Device Coordination Group (MDCG) Â has released a detailed guidance document titled " Qualification of In Vitro Diagnostic...
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Sharan Murugan
Oct 6, 20242 min read
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
The European Medicines Agency (EMA)Â recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...
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Sharan Murugan
Oct 6, 20242 min read
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation "Â which provides detailed...
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Sharan Murugan
Oct 2, 20242 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA)Â has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
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Sharan Murugan
Oct 2, 20242 min read
UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA)Â updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
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