Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval

Inappropriate use of progression-free survival in cancer drug approvals

(2020) Huseyin Naci et al.   BMJ-British Medical Journal

New agreement on branded drugs for the NHS

(2019) Huseyin Naci et al.   BMJ-British Medical Journal

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

(2019) Bishal Gyawali et al.   JAMA Internal Medicine

Specialty Drug Coverage Varies Across Commercial Health Plans In The US

(2018) James D. Chambers et al.   HEALTH AFFAIRS

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics

(2018) Julia A. Beaver et al.   JAMA Oncology

Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

(2017) Huseyin Naci et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

The Fate of FDA Postapproval Studies

(2017) Steven Woloshin et al.   NEW ENGLAND JOURNAL OF MEDICINE

Accelerated Approval and Expensive Drugs — A Challenging Combination

(2017) Walid F. Gellad et al.   NEW ENGLAND JOURNAL OF MEDICINE

Accelerated access to new drugs and technologies

(2017) Huseyin Naci et al.   BMJ-British Medical Journal

Accelerated access to new drugs and technologies

(2017) Huseyin Naci et al.   BMJ-British Medical Journal

Use of surrogate end points in healthcare policy: a proposal for adoption of a validation framework

(2016) Oriana Ciani et al.   NATURE REVIEWS DRUG DISCOVERY

Approvals of drugs with uncertain benefit–risk profiles in Europe

(2015) Rita Banzi et al.   European Journal of Internal Medicine

The Strength of Association Between Surrogate End Points and Survival in Oncology

(2015) Vinay Prasad et al.   JAMA Internal Medicine

Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

(2012) Nicholas S. Downing et al.   NEW ENGLAND JOURNAL OF MEDICINE