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Morel C, McClure L, Edwards S, et al., editors. Ensuring innovation in diagnostics for bacterial infection: Implications for policy [Internet]. Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2016. (Observatory Studies Series, No. 44.)
Ensuring innovation in diagnostics for bacterial infection: Implications for policy [Internet].
Show details- ADEPT
Autonomous Diagnostics to Enable Prevention and Therapeutics
- AHRQ
Agency for Healthcare Research and Quality
- AMA
American Medical Association
- AMCP
Academy of Managed Care Pharmacy
- APC
Ambulatory Payment Classification
- APEC
Asia-Pacific Economic Cooperation
- ASPR
Assistant Secretary for Preparedness and Response
- AWARE
Alliance Working for Antibiotic Resistance Education
- BARDA
Biomedical Advanced Research and Development Authority
- BBMRI
European Biobanking and Biomolecular Resources Infrastructure
- BCBS
BlueCross BlueShield Association
- BIVDA
British In Vitro Diagnostics Association
- CAD
Canadian dollars
- CDC
Centers for Disease Control and Prevention
- CDDEP
Center for Disease Dynamics, Economics & Policy
- CED
Coverage with evidence development
- CEN
European Committee for Standardization
- CENELEC
European Committee for Electrotechnical Standardization
- CER
Comparative effectiveness research
- CFR
Code of Federal Regulations
- CLIA
Clinical Laboratory Improvement Amendments
- CMS
Centers for Medicare and Medicaid Services
- CPI
Consumer price index
- CPT
Current Procedural Technology
- CQUIN
Commissioning for Quality and Innovation
- DAP
Diagnostics assessment programme
- DARPA
Defense Advanced Research Projects Agency
- DEcIDE
Developing Evidence to Inform Decisions about Effectiveness
- DG
Directorate-General
- DHHS
Department of Health and Human Services (United States)
- DNA
Deoxyribonucleic acid
- DRG
Diagnosis-related group
- EARS-Net
European Antimicrobial Resistance Surveillance Network
- EC
European Commission
- ECDC
European Centre for Disease Prevention and Control
- EDMA
European Diagnostic Manufacturers Association
- EEA
European Economic Area
- EPCs
Evidence-based practice centers
- ESAC-Net
European Surveillance of Antimicrobial Consumption Network
- ESO
European Standards Organization
- EU
European Union
- EUA
Emergency Use Authorization
- EUDAMED
European Database on Medical Devices
- FDA
Food and Drug Administration
- FDASIA
Food and Drug Administration Safety and Innovation Act
- FDC
Federal Food, Drug, and Cosmetic Act
- FP7
7th Framework Programme for Research and Technological Development
- GAS
Group A β-haemolytic streptococcus
- GBP
British pound
- GHTF
Global Harmonization Task Force
- GPs
General practitioners
- GPOs
Group purchasing organizations
- HAI
Hospital acquired infections
- HGC
Human Genetics Commission
- HRGs
Health-related groups
- ICU
Intensive care unit
- IDE
Investigations Device Exemption
- IDSA
Infectious Diseases Society of America
- IMDRF
International Medical Device Regulators Forum
- IMI
Innovative Medicines Initiative
- IP
Intellectual property
- IPPS
Inpatient Prospective Payment System
- IRB
Institutional review board
- ISO
International Organization for Standards
- IUO
Investigational use only
- IVD
In vitro diagnostic/s
- IVDD
In Vitro Diagnostic Medical Devices Directive
- JEREMIE
Joint European Resources for Micro to Medium Enterprises
- LCD
Local coverage decisions
- LDT
Laboratory-developed test
- LOS
Length of stay
- LPAD
Limited population antibacterial drug
- LSIF
Life Sciences Innovation Forum
- MAC
Medicare administrative contractors
- MDR
Multi-drug resistant
- MDUFA
Medical Device User Fee Amendments
- MDUFMA
Medical Device User Fee and Modernization Act
- MHRA
Medicines and Healthcare products Regulatory Agency
- MODDERN Cures Act
Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Act
- MRSA
Methicillin-resistant Staphylococcus aureus
- MS-DRG
Severity-adjusted diagnostic related groups
- MTB
Mycobacterium tuberculosis
- NBs
Notified Bodies
- NCD
National coverage decisions
- NHS
National Health Service (United Kingdom)
- NIAID
National Institute of Allergy and Infectious Diseases
- NICE
National Institute for Health and Clinical Excellence
- NIH
National Institutes of Health (United States)
- NIHR
National Institute for Health Research
- NLA
National limitation amount
- OPPS
Outpatient prospective payment system
- PCOR
Patient-centered outcomes research
- PCORI
Patient-Centered Outcomes Research Institute
- PCR
Polymerase chain reaction
- PHC
Personalized health care
- PMA
Pre-market approval
- POC
Point-of-care
- POCT
Point-of-care tests
- POCTRN
POC Technologies Research Network
- PPP
Public–private partnership
- PwC
PricewaterhouseCoopers
- QALY
Quality-adjusted life year
- QSR
Quality System Regulations
- R&D
Research and development
- RCT
Randomized control trial
- RHSC
LSIF Regulatory Harmonization Steering Committee
- RNA
Ribonucleic acid
- RUO
Research use only
- SACGHS
Secretary’s Advisory Committee on Genetics, Health, and Society
- SBIR
Small Business Innovation Research
- SBRI
Small Business Research Initiative
- SIRS
Systemic inflammatory response syndrome
- SME
Small- and medium-sized enterprises
- SSI
Surgical site infection
- STI
Sexually transmitted infection
- STTR
Small Business Technology Transfer
- TB
Tuberculosis
- TEC
Technology Evaluation Center
- TPPs
Target Product Profiles
- TSN
The Surveillance Network
- TTIP
Transatlantic Trade and Investment Partnership
- UDI
Unique Device Identifier
- USPSTF
United States Preventive Services Task Force
- USPTO
United States Patent and Trademark Office
- UTI
Urinary tract infection
- VA
United States Department of Veterans Affairs
- List of abbreviations - Ensuring innovation in diagnostics for bacterial infecti...List of abbreviations - Ensuring innovation in diagnostics for bacterial infection
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