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USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
Feb 7, 20242 min read
30 views
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Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...
Sharan Murugan
Feb 7, 20242 min read
40 views
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USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...
Sharan Murugan
Feb 4, 20242 min read
22 views
0 comments
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...
Sharan Murugan
Jan 28, 20242 min read
25 views
0 comments
WHO Guidance: Ethics and Governance of Artificial Intelligence for Health
The World Health Organization (WHO) released new guidelines (18 January 2023) on ethics and governance of large multi-modal models...
Sharan Murugan
Jan 20, 20241 min read
100 views
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MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...
Sharan Murugan
Jan 18, 20242 min read
94 views
0 comments
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...
Sharan Murugan
Jan 16, 20242 min read
50 views
0 comments
South Africa's (SAPHRA): Import Applications Of Electronic Devices Emitting Ionizing Radiation
Earlier today (16 January, 2024) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline For...
Sharan Murugan
Jan 16, 20241 min read
17 views
0 comments
USFDA Guidance: Requests for Reconsideration under GDUFA
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Jan 13, 20242 min read
32 views
0 comments
EMA: Guidance on Paediatric Submissions & Scientific Guidelines with SmPC Recommendations
Developing drugs specifically for paediatric use comes with its own set of challenges, including ethical considerations, appropriate...
Sharan Murugan
Jan 13, 20241 min read
91 views
0 comments
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
Sharan Murugan
Jan 9, 20241 min read
43 views
0 comments
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day...
Sharan Murugan
Jan 5, 20242 min read
164 views
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UK MHRA: Guidance on Operational Information Sharing
Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational...
Sharan Murugan
Jan 2, 20241 min read
36 views
0 comments
India CDSCO: Launching of National Single Window System (NSWS) Portal
To address the challenges in the management of medical devices, India's Central Drugs Standard Control Organization (CDSCO) has...
Sharan Murugan
Jan 2, 20241 min read
42 views
0 comments
Saudi Arabia’s (SFDA): Requirements for Clinical Trials of Medical Devices
The Saudi Food and Drug Authority (SFDA) issued a comprehensive updated guidance titled "Requirements for Clinical Trials of Medical...
Sharan Murugan
Dec 30, 20231 min read
31 views
0 comments
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Dec 30, 20232 min read
14 views
0 comments
USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Dec 27, 20232 min read
19 views
0 comments
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
Earlier this week the the U.S. Food and Drug Administration (FDA)Â released multiple guidances that is related to Digital Technologies and...
Sharan Murugan
Dec 27, 20232 min read
8 views
0 comments
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting...
Sharan Murugan
Dec 27, 20232 min read
48 views
0 comments
Malaysia NPRA: Guidelines for Registration of Biosimilars in Malaysia
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (13 December 2023) released an updated guidance on "Guidelines for...
Sharan Murugan
Dec 19, 20231 min read
53 views
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