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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...
Sharan Murugan
Jul 31, 20243 min read
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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...
Sharan Murugan
Jul 29, 20242 min read
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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...
Sharan Murugan
Jul 27, 20242 min read
10 views
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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...
Sharan Murugan
Jul 27, 20242 min read
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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...
Sharan Murugan
Jul 27, 20242 min read
103 views
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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...
Sharan Murugan
Jul 23, 20242 min read
18 views
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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...
Sharan Murugan
Jul 23, 20242 min read
12 views
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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...
Sharan Murugan
Jul 22, 20242 min read
27 views
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SAPHRA Guidance: Guideline On Co-Applicancy
The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...
Sharan Murugan
Jul 20, 20241 min read
15 views
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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...
Sharan Murugan
Jul 20, 20242 min read
7 views
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EMA Guidance: EudraVigilance Registration Manual
Yesterday the European Medicines Agency (EMA) provided an updated comprehensive guidance on EudraVigilance registration through its...
Sharan Murugan
Jul 20, 20242 min read
38 views
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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...
Sharan Murugan
Jul 16, 20242 min read
17 views
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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...
Sharan Murugan
Jul 15, 20242 min read
86 views
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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...
Sharan Murugan
Jul 13, 20242 min read
18 views
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Swissmedic Guidance: Product Information for Human Medicinal Products
The Swissmedic released an updated guidance "Product information for Human Medicinal Products" which provides comprehensive instructions...
Sharan Murugan
Jul 13, 20242 min read
17 views
0 comments
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...
Sharan Murugan
Jul 13, 20242 min read
12 views
0 comments
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...
Sharan Murugan
Jul 11, 20242 min read
44 views
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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...
Sharan Murugan
Jul 10, 20242 min read
17 views
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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...
Sharan Murugan
Jul 9, 20242 min read
15 views
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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...
Sharan Murugan
Jul 8, 20242 min read
52 views
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