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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...
118 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...
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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:...
47 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A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...
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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...
109 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...
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Sharan Murugan
Oct 2, 20232 min read
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...
13 views0 comments
Sharan Murugan
Oct 2, 20231 min read
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Cybersecurity in...
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Sharan Murugan
Oct 1, 20232 min read
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
Recently this Friday (29-Sepetember, 2023), the European Commission's Clinical Trials Coordination and Advisory Group released an updated...
100 views0 comments
Sharan Murugan
Oct 1, 20231 min read
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
Last Friday (29 September 2023) the European Medicines Agency released an updated guidance on "European Medicines Agency...
33 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 25, 20232 min read
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...
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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...
22 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
Sharan Murugan
Sep 20, 20232 min read
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...
26 views0 comments
Sharan Murugan
Sep 11, 20231 min read
TGA Guidance: Submitting data in the eCTD format
Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...
119 views0 comments
Sharan Murugan
Sep 11, 20232 min read
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
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Sharan Murugan
Sep 10, 20232 min read
USFDA Guidance: Premarket Notification [510(k)] Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...
24 views0 comments
Sharan Murugan
Sep 10, 20232 min read
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
11 views0 comments