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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...
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...
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...
Sharan Murugan
Nov 27, 20221 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;...
Sharan Murugan
Nov 27, 20222 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...
Sharan Murugan
Nov 27, 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...
Sharan Murugan
Nov 23, 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...
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...
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...
Sharan Murugan
Nov 19, 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...
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...
Sharan Murugan
Nov 16, 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...
Sharan Murugan
Nov 12, 20221 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...
Sharan Murugan
Nov 12, 20222 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...
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...
Sharan Murugan
Nov 12, 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...
Sharan Murugan
Nov 8, 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,...
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...
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...
Sharan Murugan
Nov 4, 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...
Sharan Murugan
Nov 1, 20221 min read