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Sharan Murugan
May 25, 20232 min read
USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints
Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...
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Sharan Murugan
May 25, 20232 min read
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...
143 views0 comments
Sharan Murugan
May 24, 20232 min read
USFDA Guidance: GASK in Drug & Biologics: Nonclinical Info & Slide Imaging in Nonclinical Toxicology
Earlier today (25 May, 2023) the United States Food & Drug Administration released two guidelines "Generally Accepted Scientific...
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Sharan Murugan
May 21, 20231 min read
South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1
Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...
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Sharan Murugan
May 18, 20232 min read
USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations
The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...
21 views0 comments
Sharan Murugan
May 18, 20231 min read
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...
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Sharan Murugan
May 13, 20231 min read
USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products
This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...
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Sharan Murugan
May 13, 20232 min read
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...
61 views0 comments
Sharan Murugan
May 9, 20231 min read
South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS
Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...
102 views1 comment
Sharan Murugan
May 9, 20232 min read
Ireland's HPRA: Guidance on Reporting & Investigation of Quality Defects
Irelands Health Products Regulatory Authority (HPRA) released final guidance on "Reporting and Investigation of Quality Defects in...
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Sharan Murugan
May 7, 20231 min read
Swiss Medic: Guidance on Transfer of Marketing Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...
44 views0 comments
Sharan Murugan
May 7, 20232 min read
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
Last Week (03 May 2023) the European Medicines Agency released an Interim guidance document on "How to Approach the Protection of...
316 views0 comments
Sharan Murugan
May 4, 20231 min read
USFDA Guidance: Assessing User Fees Under the PDUFA of 2022
This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
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Sharan Murugan
May 4, 20231 min read
ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management
Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...
61 views0 comments
Sharan Murugan
May 4, 20231 min read
Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD
On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...
131 views0 comments
Sharan Murugan
May 2, 20232 min read
USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices
Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...
16 views0 comments
Sharan Murugan
Apr 29, 20231 min read
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...
37 views0 comments
Sharan Murugan
Apr 29, 20232 min read
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
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Sharan Murugan
Apr 29, 20231 min read
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...
33 views0 comments
Sharan Murugan
Apr 23, 20231 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...
49 views0 comments