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Sharan Murugan
Feb 27, 20231 min read
EMA Procedural Advice: Recommendations on Unforeseen Variations
Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...
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Sharan Murugan
Feb 21, 20232 min read
USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...
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Sharan Murugan
Feb 19, 20232 min read
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
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Sharan Murugan
Feb 16, 20231 min read
Swiss Medic Guidance: Document on Formal requirements
Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...
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Sharan Murugan
Feb 14, 20231 min read
SFDA Med.Dev: Guidance on National Diagnostic Reference Levels
The Saudi Food and Drug Authority (SFDA) released an updated guidance (7th February, 2023) on "National Diagnostic Reference Levels"....
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Sharan Murugan
Feb 14, 20231 min read
EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices
The Medical Device Coordination Group (MDCG) released an updated guidance on "Classification Rules for In-vitro Diagnostic Medical...
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Sharan Murugan
Feb 14, 20231 min read
EMA Checklist: Updated Validation checklist for Type II quality variations
Recently on 10th February 2023, the European Medicines Agency (EMA) updated and released their "Validation checklist for Type II quality...
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Sharan Murugan
Feb 9, 20231 min read
Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs
Earlier today (09-January-2022), the Drug Regulatory Authority of Pakistan released an updated guidance on "Good Manufacturing Practices...
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