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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...
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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Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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Sharan Murugan
Mar 30, 20232 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...
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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 28, 20231 min read
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...
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Sharan Murugan
Mar 27, 20232 min read
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...
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Sharan Murugan
Mar 27, 20231 min read
UK MHRA: Guidance on Register Medical Devices to place on the Market
Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...
109 views0 comments
Sharan Murugan
Mar 24, 20231 min read
USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19
On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...
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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...
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Sharan Murugan
Mar 22, 20231 min read
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD
Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...
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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...
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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...
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Sharan Murugan
Mar 14, 20231 min read
Malaysia’s MDA : Guidance on Classification of Rehabilitation, Physiotherapy & Speech Therapy Device
Malaysia’s Ministry of Health Medical Device Authority (MDA) division recently updated its "Guidelines on Classification of...
39 views0 comments
Sharan Murugan
Mar 13, 20231 min read
Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...
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Sharan Murugan
Mar 11, 20231 min read
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
144 views1 comment
Sharan Murugan
Mar 11, 20231 min read
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...
191 views0 comments
Sharan Murugan
Mar 8, 20231 min read
SAPHRA Guideline: Questions And Answers Licensing Of Medical Device Establishments
Recently this week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline On Questions And...
65 views0 comments
Sharan Murugan
Mar 4, 20231 min read
Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...
137 views0 comments