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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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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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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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

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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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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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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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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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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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