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@nicolecimbura @FDA @AmylyxPharma @klink52 @ThurmanTough @SarahNauser @JamieRoseBerryy @RepJasonCrow Considering patient input is required by PDUFA this decision is beyond heartbreaking. https://t.co/TlEZxuB6rK
@nicolecimbura @FDA @AmylyxPharma @klink52 @ThurmanTough @SarahNauser @JamieRoseBerryy @RepJasonCrow Considering patient input is required by PDUFA this decision is beyond heartbreaking. https://t.co/TlEZxuB6rK
良い取り組みですね〜
FDAでは「患者にフォーカスした医薬品開発(PFDD: Patient-Focused Drug Development)」で、体系的に患者の経験、視点、ニーズなどを医薬品の開発や承認審査に取り入れることを目的に、各ステークホルダーが参加する会合を疾患別に開催している。素晴らしい取り組み✨ https://t.co/gE0Yd8qght
RT @US_FDA: A8: The lessons learned from FDA's Patient-Focused Drug Development mtgs range from experiences common across rare diseases to…