SBIR https://www.sbir.gov/

EU Horizon 2020 Program http://ec.europa.eu/programmes/horizon2020/

European Bio Organization http://www.europabio.org/

Biotechnology In Europe Report http://www.europabio.org/sites/default/files/report/ey-europabio_report_final_1.pdf

CRO Outlook and Drug Development Tools

Improving Quality and Efficiency in Health Care through Comparative Effectiveness Analyses: An International Perspective ​http://www.academyhealth.org/files/publications/2014CERImprovingQuality.pdf

Deloitte 2015 Global life sciences outlook - Adapting in an era of transformation http://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-life-sciences-report.pdf

The three rules in medical technology – The transformation of an industry, by Glenn Snyder, Faruk Abdullah, and Michael Lefferts (http://dupress.com/articles/three-rules-medical-technology/).

Valuation Drivers for Emerging Medical Device Companies http://www.s2nhealth.com/pages/blog/2014/10/28/valuation-drivers-for-emerging-medical-device-companies

2014-2018 FDA Strategic Priorities: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm227527.htm

FDA Impact on US Medical Technology Innovation http://advamed.org/res.download/30

Erik Vollebregt’s blog http://medicaldeviceslegal.com/

Qmed http://www.qmed.com/

AdvaMed http://advamed.org/

Eucomed http://www.eucomed.com/

Mass Device http://www.massdevice.com/

Medical Device and Diagnostic Industry http://www.mddionline.com/mx

Pharma and Med Tech Business Intelligence https://www.pharmamedtechbi.com/

The Life Science Report http://www.thelifesciencesreport.com/

Life Science Nation http://www.lifesciencenation.com/

The Gray Sheet https://www.pharmamedtechbi.com/publications/the-gray-sheet/about

Center for Medicare and Medicaid Regulations and Guidance http://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance.html

2014 Clinical Quality Measure (CQM) Electronic Reporting Guide http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/CQM2014_GuideEP.pdf

Priority Medicines for Europe and the World "A Public Health Approach to Innovation" Update on 2004 Background Paper by David Henry, Danielle Lang and Suzanne Hill http://www.who.int/medicines/areas/priority_medicines/BP8_3_pricing.pdf

Medicare Coverage Related to Investigational Device Exemption (IDE) Studies http://www.cms.gov/Medicare/Coverage/IDE/

ICD-9-CM, ICD-10-CM, ICD-10-PCS, CPT, AND HCPCS Code Sets http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

Healthcare Cost and Utilization Project (HCUP) http://www.hcup-us.ahrq.gov/

Agency for Healthcare Research and Quality (AHRQ) http://www.ahrq.gov/

Centers for Disease Control (CDC) and Prevention http://www.cdc.gov/

FDA Warning Letters http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/

FDA Recalls http://www.fda.gov/Safety/Recalls/default.htm

FDA Regulations http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

Office of Inspector General US Department of Health and Human Services https://oig.hhs.gov/

FDA Inspections, Compliance, Enforcement, and Criminal Investigations http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176738.htm

European Commission (EC) Internal Market, Industry, Entrepreneurship, and SMEs http://ec.europa.eu/growth/sectors/medical-devices/documents/guidelines/index_en.htm

Clinical Trials www.clinicaltrials.gov

Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials http://www.pcori.org/assets/Standards-for-the-Design-Conduct-and-Evaluation-of-Adaptive-Randomized-Clinical-Trials.pdf

CONSORT Transparent Reporting of Trials http://www.consort-statement.org/

UK Trade and Investment https://www.gov.uk/government/organisations/uk-trade-investment

​​RESOURCES

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