Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

JAMA - Journal of the American Medical Association - United States
doi 10.1001/jama.2018.7619
Full Text
Abstract

Available in full text

Categories
Medicine
Date
Authors
Publisher

American Medical Association (AMA)

Related search

FDA Approval of New Drugs

JAMA - Journal of the American Medical Association
Medicine
2014English

FDA Approval of Obesity Drugs

JAMA - Journal of the American Medical Association
Medicine
2012English

Breakthrough Therapy Status €“ Expedited FDA Regulatory Approval but What About the Payers?

Value in Health
MedicineHealth PolicyPublic HealthOccupational HealthEnvironmental
2015English

Registration, Results Reporting, and Publication Bias of Clinical Trials Supporting FDA Approval of Neuropsychiatric Drugs Before and After FDAAA: A Retrospective Cohort Study

Trials
MedicinePharmacology
2018English

FDA Oversight of Cell Therapy Clinical Trials

Science Translational Medicine
Medicine
2012English

How to Design a Cell or Gene Therapy Clinical Trial: Advice From the FDA

Molecular Therapy
Molecular MedicineMolecular BiologyPharmacologyMedicineGeneticsDrug Discovery
2013English

Obinutuzumab Breaks Through to FDA Approval

Cancer Discovery
Oncology
2013English

From the FDA: Expanded Use Granted for Implantable Defibrillators

Journal of the American Osteopathic Association, The
MedicineAlternative MedicineComplementary
1996English

Response to FDA Commissioner's Statement on Dsuvia Approval

Addiction
MedicinePsychiatryMental Health
2019English

Amanote Research

Note-taking for researchers

Follow Amanote

© 2024 Amaplex Software S.P.R.L. All rights reserved.

Privacy PolicyRefund Policy