US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018

This cohort study evaluates how the US Food and Drug Administration (FDA) accelerated approval program has been used for nononcology drugs over a period of 26 years.

[1]  P. F. Kauff.  Group , 2000, Elegant Design.

[2]  T. J. Moore,et al.  Medicare Expenditures of Atezolizumab for a Withdrawn Accelerated Approved Indication. , 2021, JAMA oncology.

[3]  A. Kesselheim,et al.  Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study , 2021, BMJ.

[4]  R. Rubin.  Recently Approved Alzheimer Drug Raises Questions That Might Never Be Answered. , 2021, JAMA.

[5]  T. Furukawa,et al.  Accelerated approval of non-cancer drugs by the US Food and Drug Administration: A protocol for a meta-epidemiological investigation , 2020, medRxiv.

[6]  Richard Veselý,et al.  A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why , 2019, Clinical pharmacology and therapeutics.

[7]  Vinay Prasad,et al.  An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate. , 2019, JAMA internal medicine.

[8]  A. Kesselheim,et al.  Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. , 2019, JAMA internal medicine.

[9]  M. Karsdal,et al.  Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs. , 2019, Osteoarthritis and cartilage.

[10]  V. Prasad,et al.  A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology. , 2019, European journal of cancer.

[11]  L. Howie,et al.  A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review , 2018, JAMA oncology.

[12]  A. Kesselheim,et al.  Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study , 2017, British Medical Journal.

[13]  A. Kesselheim,et al.  Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration , 2017, JAMA.

[14]  J. Ioannidis,et al.  Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval , 2017, The Milbank quarterly.

[15]  A. Kesselheim,et al.  Accelerated Approval and Expensive Drugs - A Challenging Combination. , 2017, The New England journal of medicine.

[16]  Harlan M. Krumholz,et al.  Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010 , 2017, JAMA.

[17]  Jonathan J. Darrow,et al.  Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study , 2015, BMJ : British Medical Journal.

[18]  V. Prasad,et al.  The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analyses. , 2015, JAMA internal medicine.

[19]  T. Fleming,et al.  Biomarkers and surrogate endpoints in clinical trials , 2012, Statistics in medicine.

[20]  A. Kesselheim,et al.  Reputation and precedent in the bevacizumab decision. , 2011, The New England journal of medicine.

[21]  P. Keegan,et al.  Accelerated approval of oncology products: the food and drug administration experience. , 2011, Journal of the National Cancer Institute.

[22]  T. H. Allegri.  The Code of Federal Regulations , 1986 .