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Sharan Murugan
Nov 30, 20231 min read
Health Canada: Guidance on Validation rules for Regulatory Transactions in the eCTD Format
Health Canada recently published an updated guidance on "Validation rules for regulatory transactions provided to Health Canada in the...
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Sharan Murugan
Nov 15, 20232 min read
Switzerland's SwissMedic: Guidance on Formal Requirements
On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...
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Sharan Murugan
Nov 11, 20232 min read
USFDA Guidance: Real-Time Oncology Review (RTOR)
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023)...
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Sharan Murugan
Nov 7, 20231 min read
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...
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Sharan Murugan
Nov 6, 20232 min read
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
16 views0 comments
Sharan Murugan
Oct 31, 20231 min read
TGA Guidance: General Dossier Requirements
Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...
208 views0 comments
Sharan Murugan
Oct 25, 20231 min read
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...
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Sharan Murugan
Oct 23, 20232 min read
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...
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Sharan Murugan
Oct 21, 20231 min read
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...
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Sharan Murugan
Oct 17, 20232 min read
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...
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Sharan Murugan
Oct 14, 20231 min read
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two guidances earlier this week ie, "Quality...
15 views0 comments
Sharan Murugan
Oct 14, 20231 min read
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure
Yesterday (13 October 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency post-authorisation...
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Sharan Murugan
Oct 14, 20232 min read
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
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Sharan Murugan
Oct 10, 20232 min read
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants
Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development:...
49 views0 comments
Sharan Murugan
Oct 6, 20231 min read
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders
A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...
10 views0 comments
Sharan Murugan
Oct 4, 20232 min read
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications...
112 views0 comments
Sharan Murugan
Oct 2, 20232 min read
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics...
21 views0 comments
Sharan Murugan
Oct 1, 20231 min read
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland...
57 views0 comments
Sharan Murugan
Sep 21, 20232 min read
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...
23 views0 comments
Sharan Murugan
Sep 21, 20231 min read
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...
26 views0 comments