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Fda Usa Issues Final Guidance Predetermined Change Control Plan Ai Enabled Device Software
18th December 2024 - Regulatory News
FDA (USA) Issues Final Guidance on Predetermined Change…
On December 4, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance, “Marketing Submission Recommendations for …
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United States Medical Devices
Dinavisa Paraguay Approves New Guideline Good Evaluation Practices Marketing Authorization
18th December 2024 - Regulatory News
DINAVISA (Paraguay) Approves New Guideline for Good Eva…
On December 2, 2024, the National Directorate of Sanitary Surveillance (DINAVISA) introduced the “Guide to Good Evaluation Practices f…
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Pharma and Biotech Paraguay