Results 11 to 20 of about 4,498,317 (372)
JAMA Network Open, 2022 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.
Kenji Omae +3 more
semanticscholar +1 more source
Review time of oncology drugs and its underlying factors: an exploration in China
Frontiers in Pharmacology, 2023 Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We ...
Xingyue Zhu, Bao Liu
doaj +1 more source
JAMA Network Open, 2022 Key Points Question Is drug approval by the Food and Drug Administration (FDA) associated with a reduction in disparities in novel cancer treatment use among patients with cancer in the US?
T. Ermer +10 more
semanticscholar +1 more source
FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019
JAMA Internal Medicine, 2020 This retrospective review assesses the frequency of surrogate measures used for the first time vs subsequent times in a cancer setting and the surrogate’s strength of correlation with patient-centered outcomes.
E. Chen, A. Haslam, V. Prasad
semanticscholar +1 more source
Repurposing of approved cardiovascular drugs [PDF]
Journal of Translational Medicine, 2016 Research and development of new drugs requires both long time and high costs, whereas safety and tolerability profiles make the success rate of approval very low. Drug repurposing, applying known drugs and compounds to new indications, has been noted recently as a cost-effective and time-unconsuming way in developing new drugs, because they have ...
Junichi Ishida +3 more
openaire +4 more sources
Revista Panamericana de Salud Pública, 2022 Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin ...
Ivar T. van der Zee +3 more
doaj +1 more source
Clinical pharmacology and therapy, 2020 The Pharmaceuticals and Medical Devices Agency (PMDA) has approved hundreds of new drugs in recent years. We retrospectively analyzed the new drugs approved in Japan from 2008 to 2019, and identify the first‐in‐world approvals and clarify the current ...
Mototsugu Tanaka +10 more
semanticscholar +1 more source
Getting the Right Evidence After Drug Approval
Frontiers in Pharmacology, 2020 To generate comparative evidence in a timely fashion for drugs without restricting or delaying access, value-based pricing and reimbursement could be conditioned on a prospective, post-approval evidence generation plan.
Rick A. Vreman +3 more
doaj +1 more source
The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
core +2 more sources