Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway

Multimorbidity in Older Adults With Cardiovascular Disease

(2018) Daniel E. Forman et al.   JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Research Priorities to Advance the Health and Health Care of Older Adults with Multiple Chronic Conditions

(2017) Mayra Tisminetzky et al.   JOURNAL OF THE AMERICAN GERIATRICS SOCIETY

Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices

(2017) Sanket S. Dhruva et al.   JAMA Internal Medicine

Cardiac Resynchronization Therapy in Older Patients: Age Is Just a Number, and Yet …

(2016) Daniel B. Kramer et al.   JOURNAL OF CARDIAC FAILURE

Exact Sciences’ experience with the FDA and CMS parallel review program

(2015) John R Ridge et al.   EXPERT REVIEW OF MOLECULAR DIAGNOSTICS

Private Payers Disagree With Medicare Over Medical Device Coverage About Half The Time

(2015) James D. Chambers et al.   HEALTH AFFAIRS

Medicare Covers The Majority Of FDA-Approved Devices And Part B Drugs, But Restrictions And Discrepancies Remain

(2013) James D. Chambers et al.   HEALTH AFFAIRS

Current and Future State of FDA-CMS Parallel Reviews

(2012) D A Messner et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Regulation of Medical Devices in the United States and European Union

(2012) Daniel B. Kramer et al.   NEW ENGLAND JOURNAL OF MEDICINE

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes

(2012) Saptarshi Basu et al.   NEW ENGLAND JOURNAL OF MEDICINE

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices

(2009) Sanket S. Dhruva   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions

(2008) Sanket S. Dhruva   ARCHIVES OF INTERNAL MEDICINE

Medicare’s National Coverage Decisions For Technologies, 1999–2007

(2008) Peter J. Neumann et al.   HEALTH AFFAIRS