Results 21 to 30 of about 159,613 (271)

Trends in Formulary Coverage of Nonprotected Class Drugs Granted FDA Accelerated Approval. [PDF]

JAMA Netw Open
Jazowski SA, Dusetzina SB.
europepmc   +2 more sources

FDA Accelerated Approval of Pembrolizumab for Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma. [PDF]

Oncologist, 2020
Bradford D, Demko S, Jin S, Mishra-Kalyani P, Beckles AR, Goldberg KB, Lemery S, Ward A, Keegan P, Pazdur R.   +9 more
europepmc   +3 more sources

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.

JAMA
Liu ITT, Kesselheim AS, Cliff ERS.
europepmc   +3 more sources

Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021. [PDF]

JAMA Health Forum, 2022
Vokinger KN, Kesselheim AS, Glaus CEG, Hwang TJ.   +3 more
europepmc   +2 more sources

Challenges in accelerated approvals for gene therapies [PDF]

Molecular Therapy, 2023
Rafael Escandon, John D. Lantos
openalex   +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

Approvals in 2021: dangling Accelerated Approvals, drug dosing, new approvals and beyond [PDF]

Nature Reviews Clinical Oncology, 2022
In 2021, policy areas of focus for FDA Oncology included the Accelerated Approval programme, expanding eligibility criteria, dose optimization and patient-reported outcomes. The FDA continued to be active with approvals of both new drugs and supplementary applications, including three new chimeric antigen receptor T cell products, two antibody–drug ...
Lemery, Steven, Pazdur, Richard
openaire   +2 more sources

Establishing a Public Resource for Acceptable Surrogate Endpoints to Support FDA Marketing Applications

Frontiers in Medicine, 2022
Following a comprehensive and coordinated effort between CBER and CDER, FDA established a table of acceptable surrogate endpoints (SEs) to support drug marketing applications.
Abena S. Agyeman, Jeffrey N. Siegel, Christopher Leptak   +2 more
doaj   +1 more source

Development and Use of Gene Therapy Orphan Drugs—Ethical Needs for a Broader Cooperation Between the Pharmaceutical Industry and Society

Frontiers in Medicine, 2020
Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the ...
Sandor Kerpel-Fronius, Varvara Baroutsou, Sander Becker, Roberto Carlesi, Luis Collia, Brigitte Franke-Bray, Peter Kleist, Chieko Kurihara, Luis Filipe Laranjeira, Kotone Matsuyama, Shehla Naseem, Johanna Schenk, Honorio Silva   +12 more
doaj   +1 more source

A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

Journal of Pharmaceutical Policy and Practice, 2021
Background Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or ...
Joel Lexchin
doaj   +1 more source