Search
Sharan Murugan
Jun 17, 20231 min read
Health Canada Guidance: Preparation of Regulatory Activities in Non-eCTD Format
Health Canada recently (09 June, 2023) published an updated guidance on "Preparation of Regulatory Activities in Non-eCTD Format" that...
159 views0 comments
Sharan Murugan
Jun 17, 20231 min read
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...
21 views0 comments
Sharan Murugan
Jun 17, 20231 min read
EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
Recently on 09 June 2023, the European Medicines Agency released updated guidance on "Paediatric Submissions Via Syncplicity Web Client"....
67 views0 comments
Sharan Murugan
Jun 17, 20231 min read
MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
Recently (09 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on the "150-Day...
76 views0 comments
Sharan Murugan
Jun 8, 20231 min read
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...
20 views0 comments
Sharan Murugan
Jun 8, 20231 min read
USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
A final industry guidance, "Clinical Drug Interactions Studies with Combined Oral Contraceptives", was released by the United States Food...
22 views0 comments
Sharan Murugan
Jun 6, 20231 min read
Philippines FDA: Guidelines on the Application for License to Operate
Yesterday (6 June 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines on the...
212 views0 comments
Sharan Murugan
Jun 6, 20231 min read
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
12 views0 comments
Sharan Murugan
Jun 6, 20231 min read
South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems
Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...
34 views0 comments
Sharan Murugan
Jun 5, 20231 min read
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...
101 views0 comments
Sharan Murugan
Jun 4, 20232 min read
SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...
31 views0 comments
Sharan Murugan
Jun 4, 20231 min read
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...
32 views0 comments
Sharan Murugan
Jun 4, 20232 min read
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
Last week (02 June 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research, Center for Drug...
32 views0 comments
Sharan Murugan
Jun 4, 20231 min read
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...
23 views0 comments
Sharan Murugan
Jun 1, 20231 min read
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new...
30 views0 comments
Sharan Murugan
May 28, 20232 min read
Philippine FDA: Guidelines for Importation and Exportation of Finished Drug Products & Raw Materials
Last Friday (26 May 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline "Guidelines for the...
366 views0 comments
Sharan Murugan
May 28, 20232 min read
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...
33 views0 comments
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...
12 views0 comments
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...
27 views0 comments