Results 31 to 40 of about 1,709,620 (289)

Expediting treatments in the 21st century: orphan drugs and accelerated approvals

Orphanet Journal of Rare Diseases
Background In response to activated patient communities’ catalyzation, two significant efforts by the FDA to expedite treatments have now been in place for multiple decades.
Reuben Domike, G. K. Raju, Jamie Sullivan, Annie Kennedy   +3 more
doaj   +2 more sources

Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval. [PDF]

Milbank Q, 2023
Neumann PJ, Crummer E, Chambers JD, Tunis SR.   +3 more
europepmc   +3 more sources

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

JAMA Netw Open, 2021
This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
Wallach JD, Ramachandran R, Bruckner T, Ross JS.   +3 more
europepmc   +2 more sources

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

JAMA Netw Open, 2021
Ho C, Lim HJ, Regier DA.
europepmc   +2 more sources

Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab. [PDF]

Drugs Aging, 2022
Largent EA, Peterson A, Karlawish J, Lynch HF.   +3 more
europepmc   +2 more sources

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.

JAMA Intern Med, 2019
Importance The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free survival) that is expected to ...
Gyawali B, Hey SP, Kesselheim AS.
europepmc   +2 more sources

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

JAMA Intern Med, 2021
Shahzad M, Naci H, Wagner AK.
europepmc   +3 more sources

Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study. [PDF]

EClinicalMedicine
Tibau A, Cliff ERS, Romano A, Borrell M, Molto C, Kesselheim AS.   +5 more
europepmc   +3 more sources

The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab. [PDF]

Drugs
Kester R, Zalani S, Ebbinghaus S, Rubin E.   +3 more
europepmc   +3 more sources

Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022Research in context

EClinicalMedicine, 2023
Summary: Background: Accelerated approval (AA) of novel anticancer drugs based on surrogacy has attracted considerable concern globally. China National Medical Products Administration (NMPA) also established a similar conditional approval (CA) program ...
Xingxian Luo, Xin Du, Lin Huang, Qixiang Guo, Xufeng Lv, Cen Wang, Haopeng Liu, Yue Zhou, Xuecai Xue, Zhuangqi Li, Jingwen Liu, Shein-Chung Chow, Yue Yang   +12 more
doaj   +1 more source