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Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...

Sharan Murugan

May 28, 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...

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...

Sharan Murugan

May 25, 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...

Sharan Murugan

May 24, 20232 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...

Sharan Murugan

May 21, 20231 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...

Sharan Murugan

May 18, 20232 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...

Sharan Murugan

May 18, 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...

Sharan Murugan

May 13, 20231 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...

Sharan Murugan

May 13, 20232 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...

Sharan Murugan

May 9, 20231 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...

Sharan Murugan

May 9, 20232 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...

Sharan Murugan

May 7, 20231 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...

Sharan Murugan

May 7, 20232 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...

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...

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...

Sharan Murugan

May 4, 20231 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...

Sharan Murugan

May 2, 20232 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...

Sharan Murugan

Apr 29, 20231 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...

Sharan Murugan

Apr 29, 20232 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...

Sharan Murugan

Apr 29, 20231 min read