Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety-Reference-Cited by-同舟云学术

Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety

Published:2018-06-20 Issue:18 Volume:36 Page:1773-1776
ISSN:0732-183X
Container-title:Journal of Clinical Oncology
language:en
Short-container-title:JCO

Author:

Kuderer Nicole M.¹,Lyman Gary H.¹

Affiliation:

1. Nicole M. Kuderer, Advanced Cancer Research Group, Seattle, WA; and Gary H. Lyman, Fred Hutchinson Cancer Research Center, Seattle, WA

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Link

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2018.78.5592

Reference50 articles.

1. Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation

2. US Food and Drug Administration Efforts to Facilitate the Use of Expanded Access Programs

3. The changing landscape of phase I trials in oncology

4. Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

5. Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies

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