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Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017
- Source :
- JAMA internal medicine. 179(5)
- Publication Year :
- 2019
-
Abstract
- This cohort study of FDA- and drug sponsor–written communications evaluates the communication of nonefficacy benefits of new drugs approved on the basis of noninferiority trials alone.
- Subjects :
- medicine.medical_specialty
Drug Industry
Drug-Related Side Effects and Adverse Reactions
business.industry
United States Food and Drug Administration
Communication
Drug Administration Routes
Drug Compounding
Equivalence Trials as Topic
Health Care Costs
Drug Administration Schedule
Drug Costs
United States
Cohort Studies
Research Design
Family medicine
Internal Medicine
medicine
Research Letter
Humans
business
Drug Approval
health care economics and organizations
Cohort study
Subjects
Details
- ISSN :
- 21686114
- Volume :
- 179
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- JAMA internal medicine
- Accession number :
- edsair.doi.dedup.....ae61d019fe5f2d812065055569aa0291