Accelerated Approval Of Cancer Drugs: No Economic Reward For Drug Makers That Conduct Confirmatory Trials

The Food and Drug Administration uses expedited approval of drugs to speed the development and assessment of drugs that address unmet needs related to serious or life-threatening conditions. Drugs approved via this route rely on surrogate endpoints or other clinical indicators that are not direct me...

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Bibliographic Details
Published in:Health affairs (Millwood, Va.) Va.), 2022-09, Vol.41 (9), p.1273-2
Main Authors: Frank, Richard G, Shahzad, Mahnum, Emanuel, Ezekiel J
Format: Article
Language:English
Subjects:
Aged
Alzheimer's disease
Antineoplastic Agents - therapeutic use
Benefits
Cancer
Cancer therapies
Chemotherapy
Clinical indicators
Clinical research
Clinical trials
Clinical Trials as Topic
Drug Approval
Drug development
Drug effects
Drug withdrawal
Drugs
Economics
FDA approval
Food
Humans
Life threatening
Medicare
Neoplasms - drug therapy
Patients
Pharmaceutical industry
Pharmaceutical Preparations
Prices
Pricing
Quality of Life
Reinforcement
Reward
Sales
Side effects
Uncertainty
United States
United States Food and Drug Administration
Online Access:Get full text
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