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新分子実体薬および新生物学的承認のためのFDA加速プログラムおよび開発タイムラインの使用 スポンサーの経験

Kanhai S Amin1, Bhav Jain2, Alissa Wong3

  • 1Yale School of Medicine, New Haven, Connecticut, USA.

Clinical pharmacology and therapeutics
|September 5, 2025
PubMed
まとめ

バイオ製薬会社は,新しい分子実体 (NME) と新しい生物学的薬のFDAの承認を得ています. 経験が不足しているにも関わらず 彼らはFDAのプロセスを 確立された企業と同じくらい効果的に 導いています

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