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Sharan Murugan
Nov 27, 20221 min read
Malaysia’s MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Recently on 21st November, 2022 the Malaysian Medical Device Authority (MDA) updated its guidelines regarding the "Requirement for...
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Sharan Murugan
Nov 27, 20221 min read
Singapore HSA MedDev: Regulatory Guidelines for Laboratory Developed Tests (LDTs)
On 22nd November, 2022 Singapore's Health Sciences Authority released the final Regulatory Guidelines for Laboratory Developed Tests...
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Sharan Murugan
Nov 27, 20221 min read
South Africe SAPHRA Guideline: For the API Master File (APIMF) Procedure
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for the API Master File...
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Sharan Murugan
Nov 27, 20222 min read
Philippines FDA: Guidance Reliance for Regulatory Decisions & Regulatory Response on National PHE
Recently on 25th November, 2022 Philippines Food and Drug Administration (FDA) released two draft guidelines for comments i.e;...
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Sharan Murugan
Nov 27, 20221 min read
Irelands HPRA's: Medical Device Guide to Clinical Investigations Carried Out in Ireland
On 18th November, 2022 Irelands Health Products Regulatory Authority (HPRA) released an updated Guide related to "Clinical Investigations...
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Sharan Murugan
Nov 23, 20221 min read
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
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Sharan Murugan
Nov 19, 20221 min read
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...
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Sharan Murugan
Nov 19, 20221 min read
SFDA Guidance: Registration Rules of Pharmaceutical Product Manufacturers & their Products
Saudi Food & Drug Authority on 17th November 2022, released an updated guidance on "The Registration Rules of Pharmaceutical, Herbal and...
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Sharan Murugan
Nov 19, 20221 min read
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...
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Sharan Murugan
Nov 16, 20221 min read
Irelands HPRA MD Guide: Performance Studies Conducted in Ireland
Irelands Health Products Regulatory Authority (HPRA) released (16- November-2022) guide on "Performance Studies Conducted in Ireland", to...
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Sharan Murugan
Nov 16, 20221 min read
SFDA Guidance: Conditional Approval for Medicinal Products for Human Use
The Saudi Food and Drug Authority recently released (13- November-2022) updated guidance on "Conditional Approval for Medicinal Products...
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Sharan Murugan
Nov 12, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
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Sharan Murugan
Nov 12, 20222 min read
USFDA MD Guidance: Referencing “Device” and “Counterfeit Device”
According to the US Food and Drug Administration's draft guidance, the definition of a device has been updated according to the...
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Sharan Murugan
Nov 12, 20221 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
On 11 November 2022, the European medicines agency released updated guidance for sponsors about the "Procedural Advice for Orphan...
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Sharan Murugan
Nov 12, 20221 min read
MHRA Guidance: Licensing of Biosimilar Products
Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of...
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Sharan Murugan
Nov 8, 20221 min read
USFDA Guidance: Sameness Evaluations in an ANDA — Active Ingredients
Earlier today (November 8, 2022) USFDAs Center for Drug Evaluation and Research, Office of Generic Drugs released a Draft guideline on...
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Sharan Murugan
Nov 4, 20221 min read
USFDA Guidance: Multiple Biologics related Guidance - M10 Bioanalytical Method Validation
This week USFDAs Center for Biologics Evaluation and Research updated and released multiple guidances related to Gene therapy, Oncology,...
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Sharan Murugan
Nov 4, 20221 min read
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
Today (04-November-2022) European Medicines Agency, released updated guidance on "Anonymisation of Protected Personal Data and assessment...
270 views0 comments
Sharan Murugan
Nov 4, 20221 min read
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice...
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Sharan Murugan
Nov 1, 20221 min read
USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
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