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EMA Procedural Advice: Recommendations on Unforeseen Variations
Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...
Sharan Murugan
Feb 27, 20231 min read
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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,...
Sharan Murugan
Feb 21, 20232 min read
23 views
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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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
Sharan Murugan
Feb 19, 20232 min read
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Swiss Medic Guidance: Document on Formal requirements
Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...
Sharan Murugan
Feb 16, 20231 min read
84 views
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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"....
Sharan Murugan
Feb 14, 20231 min read
19 views
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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...
Sharan Murugan
Feb 14, 20231 min read
11 views
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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...
Sharan Murugan
Feb 14, 20231 min read
321 views
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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...
Sharan Murugan
Feb 9, 20231 min read
38 views
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