The Thalodomide Tragedy - Clinical Research History Series
Автор: Clinical Research x360
Загружено: 2021-02-27
Просмотров: 3711
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In the second lecture of Clinical research history series, we deeply look into the historical event of The Thalidomide Tragedy. This tragedy led to the formation of amendments which implemented in US FDA drug approval process. This resulted in approval of drugs only who present the safety and efficacy data according to the standards and focus on clinical data submitted that justifies the safety of the drug. This tragedy laid the foundation of developing guidelines that mandated higher safety standards and ethics in clinical research. Also, this video is a homage to Dr. Frances Kesley who not only saved American mothers and children from thalidomide but also a generation all around the world which could have been affected if not for her resilience and higher ethical conduct and dedication to her job and public safety.
In this Video I talk about:
1. Thalidomide Drug
2. Thalidomide tragedy
3. Thalidomide wonder drug and disaster
4. Reason for thalidomide birth defects
5. Dr Frances Kesley and US FDA approval to thalidomide
6. Kefauver Harris amendment
7. Impact of thalidomide
8. Approval and use of thalidomide
9. Future precautions and safety readiness
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