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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...
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Sharan Murugan
Oct 25, 20231 min read
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...
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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Earlier today (25 October,2023), the USFDA issued a draft guidance, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch...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, 20231 min read
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...
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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...
27 views0 comments
Sharan Murugan
Oct 21, 20232 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
Yesterday (20 October 2023) the European Medicines Agency released an updated guidance on "Procedural Advice for Orphan Medicinal Product...
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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...
55 views0 comments
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...
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Sharan Murugan
Oct 14, 20231 min read
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
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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...
142 views0 comments
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...
18 views0 comments
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:...
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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...
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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...
118 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...
24 views0 comments