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Literature DB >> 24224621

Expediting drug development--the FDA's new "breakthrough therapy" designation.

Rachel E Sherman¹, Jun Li, Stephanie Shapley, Melissa Robb, Janet Woodcock.

Abstract

The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.

Mesh：

Substances：
Drugs, Investigational

Year: 2013 PMID： 24224621 DOI： 10.1056/NEJMp1311439

Source DB: PubMed Journal: N Engl J Med ISSN： 0028-4793 Impact factor: 91.245

Keyword Cloud
Cited

30 in total

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Authors: Emily A Simons; Derek E Smith; Dexiang Gao; D Ross Camidge
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3. Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors.

Authors: Geoffrey R Oxnard; Katharine H Wilcox; Mithat Gonen; Mikhael Polotsky; Bradford R Hirsch; Lawrence H Schwartz
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4. A scalable method for molecular network reconstruction identifies properties of targets and mutations in acute myeloid leukemia.

Authors: Edison Ong; Anthony Szedlak; Yunyi Kang; Peyton Smith; Nicholas Smith; Madison McBride; Darren Finlay; Kristiina Vuori; James Mason; Edward D Ball; Carlo Piermarocchi; Giovanni Paternostro
Journal: J Comput Biol Date: 2015-04 Impact factor: 1.479

5. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

Authors: Jean-David Zeitoun; Jérémie H Lefèvre; Nicholas S Downing; Henri Bergeron; Joseph S Ross
Journal: Br J Clin Pharmacol Date: 2015-05-28 Impact factor: 4.335

6. Charting a clear path: the ASGCT Standardized Pathways Conference.

Authors: Hans-Peter Kiem; Christopher Baum; Frederic D Bushman; Barry J Byrne; Barrie J Carter; Joy Cavagnaro; Harry L Malech; Jerry R Mendell; Luigi M Naldini; Brian P Sorrentino; David A Williams; Terence R Flotte
Journal: Mol Ther Date: 2014-07 Impact factor: 11.454

Expediting drug development--the FDA's new "breakthrough therapy" designation.

Review 1. The changing landscape of phase I trials in oncology.

2. Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences.

3. Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors.

4. A scalable method for molecular network reconstruction identifies properties of targets and mutations in acute myeloid leukemia.

5. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

6. Charting a clear path: the ASGCT Standardized Pathways Conference.

7. Decade in review--clinical trials: shifting paradigms in cancer clinical trial design.

8. A survey of breakthrough therapy designations.

9. Induction of Therapeutic Senescence in Vemurafenib-Resistant Melanoma by Extended Inhibition of CDK4/6.

Review 10. From bench to FDA to bedside: US regulatory trends for new stem cell therapies.