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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
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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
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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
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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
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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
53 views
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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
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USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...
Sharan Murugan
Dec 19, 20232 min read
10 views
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Singapore's HSA: Post-Industry Consultation Updates on eCTD Implementation in Singapore
On 11th December 2023, Singapore's Health Sciences Authority (HSA) released an update "Post-Industry Consultation Updates on Electronic...
Sharan Murugan
Dec 11, 20231 min read
29 views
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Philippines FDA: Guidance on Use of FDA eServices Portal for the Initial Application of CMDN
On 4 Decemberber 2023, the Philippines FDA released draft guidelines on the "Use of the Food and Drug Administration eServices Portal...
Sharan Murugan
Dec 6, 20232 min read
92 views
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UK MHRA Guidance: Apply for a Parallel Import Licence
Earlier today (05 December 2023) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines: "Apply for...
Sharan Murugan
Dec 5, 20232 min read
133 views
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UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
Sharan Murugan
Dec 3, 20231 min read
20 views
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