[转载]EU Regulatory Workshop – Ophthalmology – Summary and Report 2024-09-20

 There  are  many  possible  visual  endpoints  that  examine  safety,  and  benefit;  th ...

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[转载]SLE - FDA guideline 2024-09-05

BACKGROUND SLE is a chronic disease characterized by protean manifestations, often with a waxing and waning course.  In the past, a diagnosi ...

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[转载]SLE - EMA guideline 2024-09-05

4.  Patient selection/diagnostic criteria 4.1. Systemic Lupus Participating patients should have a definite diagnosis of SLE based on gen ...

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[转载]Fabry Disease: Developing Drugs for Treatment Guidance for 2024-07-09

I.    INTRODUCTION The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features ...

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[转载]EMA: NOTIFICATION OF AMENDMENTS AND RELATED MEASUR 2024-06-20

3.  NOTIFICATION   OF    AMENDMENTS   AND    RELATED MEASURES 3.1.  Legal basis and s ...

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[转载]Management of Adults and Children receiving CAR T-cell thera 2024-06-11

ABSTRACT: Background: Several commercial and academic autologous chimeric antigen receptor T-cell products targeting ...

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[转载]Onasemnogene abeparvovec基因疗法治疗症状性婴儿型脊髓性肌萎缩症1型-part2 2024-05-21

Onasemnogene abeparvovec 基因疗法治疗症状性婴儿型脊髓性肌萎缩症 1 型   Summary  摘要 Background Spinal muscular atrophy is a r ...

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