💊 दवाएँ A-Z 🧬 लक्ष्य 🛠 उपकरण 📚 मार्गदर्शिकाएँ
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Accelerated Approval

Regulatory

FDA pathway allowing approval based on surrogate endpoints reasonably likely to predict clinical benefit. Requires post-marketing confirmatory trials. Can be withdrawn if benefit not confirmed.

उदाहरण

  • Tumor response rate as surrogate
  • CD4 count for HIV drugs
  • Recent withdrawals for unconfirmed benefit

क्या आप जानते हैं?

FDA pathway allowing approval based on surrogate endpoints reasonably likely to predict clinical benefit. Requires post-marketing confirmatory trials. Can be withdrawn if benefit not confirmed.