Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018

Therapeutic Agents ◽

Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval

Milbank Quarterly ◽

10.1111/1468-0009.12261 ◽

2017 ◽

Vol 95 (2) ◽

pp. 261-290 ◽

Cited By ~ 21

Author(s):

HUSEYIN NACI ◽

OLIVIER J. WOUTERS ◽

RADHIKA GUPTA ◽

JOHN P.A. IOANNIDIS

Keyword(s):

Drug Administration ◽

Therapeutic Agents ◽

Accelerated Approval ◽

Cumulative Evidence ◽

Novel Therapeutic

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval

JAMA Network Open ◽

10.1001/jamanetworkopen.2021.33667 ◽

2021 ◽

Vol 4 (11) ◽

pp. e2133667

Author(s):

Joshua D. Wallach ◽

Audrey D. Zhang ◽

Joshua J. Skydel ◽

Victoria L. Bartlett ◽

Sanket S. Dhruva ◽

...

Keyword(s):

Clinical Trials ◽

Drug Administration ◽

Real World ◽

Therapeutic Agents ◽

Real World Data ◽

World Data ◽

Accelerated Approval ◽

Confirmatory Clinical Trials

Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval

JAMA Internal Medicine ◽

10.1001/jamainternmed.2021.5989 ◽

2021 ◽

Author(s):

Mahnum Shahzad ◽

Huseyin Naci ◽

Anita K. Wagner

Keyword(s):

Drug Administration ◽

Clinical Benefit ◽

Cancer Drug ◽

Accelerated Approval ◽

Medicare Spending

Gleevec ™ for the Treatment of Chronic Myelogenous Leukemia: U.S. Food and Drug Administration Regulatory Mechanisms, Accelerated Approval, and Orphan Drug Status

The Oncologist ◽

10.1634/theoncologist.7-5-390 ◽

2002 ◽

Vol 7 (5) ◽

pp. 390-392 ◽

Cited By ~ 24

Author(s):

Martin H. Cohen ◽

Marie L. Moses ◽

Richard Pazdur

Keyword(s):

Chronic Myelogenous Leukemia ◽

Orphan Drug ◽

Drug Administration ◽

Orphan Drug Status ◽

Myelogenous Leukemia ◽

Regulatory Mechanisms ◽

Drug Status ◽

Small-Molecule Screens: A Gateway to Cancer Therapeutic Agents with Case Studies of Food and Drug Administration–Approved Drugs

Pharmacological Reviews ◽

10.1124/pr.117.013755 ◽

2017 ◽

Vol 69 (4) ◽

pp. 479-496 ◽

Cited By ~ 30

Author(s):

Nathan P. Coussens ◽

John C. Braisted ◽

Tyler Peryea ◽

G. Sitta Sittampalam ◽

Anton Simeonov ◽

...

Keyword(s):

Case Studies ◽

Drug Administration ◽

Small Molecule ◽

Therapeutic Agents ◽

Approved Drugs

Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015

JAMA Network Open ◽

10.1001/jamanetworkopen.2020.9498 ◽

2020 ◽

Vol 3 (7) ◽

pp. e209498 ◽

Cited By ~ 1

Author(s):

Andrea MacGregor ◽

Audrey D. Zhang ◽

Joshua D. Wallach ◽

Joseph S. Ross ◽

Matthew Herder

Keyword(s):

Drug Administration ◽

Therapeutic Agents ◽

The Us ◽

Novel Therapeutic

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

JAMA ◽

10.1001/jama.2017.9415 ◽

2017 ◽

Vol 318 (7) ◽

pp. 626 ◽

Cited By ~ 60

Author(s):

Huseyin Naci ◽

Katelyn R. Smalley ◽

Aaron S. Kesselheim

Keyword(s):

Drug Administration ◽

The Us ◽

Osteoarthritis clinical trial design and food and drug administration accelerated approval: lessons learned from the osteoporosis and liver fibrosis fields

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2018.02.024 ◽

2018 ◽

Vol 26 ◽

pp. S5-S6

Author(s):

M.A. Karsdal

Keyword(s):

Clinical Trial ◽

Liver Fibrosis ◽

Drug Administration ◽

Trial Design ◽

Clinical Trial Design ◽

Lessons Learned ◽

Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program

JAMA Network Open ◽

10.1001/jamanetworkopen.2021.20301 ◽

2021 ◽

Vol 4 (8) ◽

pp. e2120301

Author(s):

Cheryl Ho ◽

Howard J. Lim ◽

Dean A. Regier

Keyword(s):

Health Technology Assessment ◽

Drug Administration ◽

Technology Assessment ◽

Health Technology ◽

The Us ◽

Registration by the European Agency for the Evaluation of Medicinal products (EMEA) of oncology products approved by the Food and Drug Administration (FDA) under accelerated approval (AA) regulations

Journal of Clinical Oncology ◽

10.1200/jco.2005.23.16_suppl.6054 ◽

2005 ◽

Vol 23 (16_suppl) ◽

pp. 6054-6054 ◽

Cited By ~ 1

Author(s):

L. Talarico ◽

F. Pignatti ◽

R. Pazdur

Keyword(s):

Drug Administration ◽

Medicinal Products ◽

Accelerated Approval ◽

European Agency