Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe

Tepid Steps on Drug Pricing

(2019) Ameet Sarpatwari et al.   JAMA Internal Medicine

Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015

(2019) N. Grössmann et al.   EUROPEAN JOURNAL OF CANCER

Added therapeutic benefit and drug licensing

(2019) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

(2019) Bishal Gyawali et al.   JAMA Internal Medicine

The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations

(2018) Giovanni Tafuri et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Post-authorisation changes to specific obligations of conditionally authorised medicines in the EU: a retrospective cohort study

(2018) Lourens T Bloem et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements

(2018) Joshua D Wallach et al.   Clinical Trials

Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines

(2018) Lisette Pregelj et al.   HEALTH AFFAIRS

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

(2018) Thomas J. Hwang et al.   JOURNAL OF CLINICAL ONCOLOGY

Reinforcing the social compromise of accelerated approval

(2018) Bishal Gyawali et al.   Nature Reviews Clinical Oncology

The FDA Breakthrough-Drug Designation — Four Years of Experience

(2018) Jonathan J. Darrow et al.   NEW ENGLAND JOURNAL OF MEDICINE

Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016

(2018) Marjorie Zettler et al.   JAMA Oncology

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

Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs

(2018) Rick A. Vreman et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

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 FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

(2017) Thomas J. Hwang et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

From screening to synthesis: usingnvivoto enhance transparency in qualitative evidence synthesis

(2017) Catherine Houghton et al.   JOURNAL OF CLINICAL NURSING

Approvals in 2016: questioning the clinical benefit of anticancer therapies

(2017) Christopher M. Booth et al.   Nature Reviews Clinical Oncology

Accelerated Approval and Expensive Drugs — A Challenging Combination

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

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

(2017) Courtney Davis et al.   BMJ-British Medical Journal

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

(2017) Courtney Davis et al.   BMJ-British Medical Journal

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

(2017) Lawrence Liberti et al.   Frontiers in Pharmacology

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation

(2017) Patricia Vella Bonanno et al.   Frontiers in Pharmacology

Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

(2016) J. C. Del Paggio et al.   ANNALS OF ONCOLOGY

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice

(2016) Giovanni Tafuri et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways

(2016) Michael Ermisch et al.   Frontiers in Pharmacology

From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients

(2015) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

(2015) Aaron S Kesselheim et al.   BMJ-British Medical Journal

Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

(2015) Aaron S Kesselheim et al.   BMJ-British Medical Journal

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

(2015) Vinay Prasad et al.   JAMA Internal Medicine

Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival

(2015) Chul Kim et al.   JAMA Internal Medicine

FDA Designations for Therapeutics and Their Impact on Drug Development and Regulatory Review Outcomes

(2015) AS Kesselheim et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Accelerated Access to Innovative Medicines for Patients in Need

(2014) L G Baird et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

(2014) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

New FDA Breakthrough-Drug Category — Implications for Patients

(2014) Jonathan J. Darrow et al.   NEW ENGLAND JOURNAL OF MEDICINE