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Sharan Murugan
Jul 31, 20243 min read
USFDA Guidance: User Fee Programs: GDUFA, BSUFA, OMOR, and MDUFA
On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates...
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Sharan Murugan
Jul 29, 20242 min read
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...
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Sharan Murugan
Jul 27, 20242 min read
USFDA Guidance: Utilizing Real-World Data in Regulatory Decision-Making for Drug and Biological Products
On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...
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Sharan Murugan
Jul 27, 20242 min read
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...
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Sharan Murugan
Jul 27, 20242 min read
USFDA Guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research...
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Sharan Murugan
Jul 23, 20242 min read
Swissmedic Guidance: Electronic exchange of ICSRs through PV Gateway
Yesterday (23 July, 2024) Swissmedic, the Swiss Agency for Therapeutic Products, has released updated guidance " Electronic exchange of...
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Sharan Murugan
Jul 23, 20242 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on " Good Clinical...
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Sharan Murugan
Jul 22, 20242 min read
USFDA Q&A Guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products
Today (23 July,2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics...
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Sharan Murugan
Jul 20, 20241 min read
SAPHRA Guidance: Guideline On Co-Applicancy
The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...
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Sharan Murugan
Jul 20, 20242 min read
USFDA Guidance: Pediatric IBD Drug Development, Clin.Pharmacology Considerations and BP-Pulse Donor Eligibility Requirements
The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research recently released updated guidelines "Pediatric...
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Sharan Murugan
Jul 19, 20242 min read
EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
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Sharan Murugan
Jul 16, 20242 min read
USFDA Guidance: Application User Fees for Combination Products
The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...
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Sharan Murugan
Jul 15, 20242 min read
New EU Regulations on AI in Medical Devices: Key Insights and Implications
The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in...
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Sharan Murugan
Jul 13, 20242 min read
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...
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Sharan Murugan
Jul 13, 20242 min read
Swissmedic Guidance: Product Information for Human Medicinal Products
The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...
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Sharan Murugan
Jul 13, 20242 min read
USFDA MD Guidance: Dental Curing Lights & Composite Resin - Premarket Notification (510(k)) Submissions & Devices Intended to Treat OUD
The US Food and Drug Administration (USFDA) Center for Devices and Radiological Health recently released updated guidelines for dental...
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Sharan Murugan
Jul 11, 20242 min read
EU Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) provides detailed guidance "Procedural Advice on Paediatric Applications" that aims to facilitate the...
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Sharan Murugan
Jul 10, 20242 min read
WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs
WHO MeDevIS platform: The World Health Organization (WHO) has established the first global open access clearing house for medical device...
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Sharan Murugan
Jul 9, 20242 min read
USFDA Guidance: Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
The US Food and Drug Administration (FDA) issued a draft guidance for the industry yesterday titled “Addressing Misinformation About...
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Sharan Murugan
Jul 8, 20242 min read
USFDA Guidance: Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products
Today (08 July, 2024) the US Food and Drug Administration (FDA) has released guidance "Purpose and Content of Use-Related Risk Analyses...
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