Results 1 to 10 of about 5,045 (167)

An empirical analysis of overall survival in drug approvals by the US FDA (2006–2023)

Cancer Medicine
Background The US Food and Drug Administration (FDA) has expanded the use of surrogate markers in drugs approved for oncology/hematology indications. This has likely resulted in a greater number of approvals and possibly drugs coming to market faster ...
Vinay Prasad, Alyson Haslam
exaly   +2 more sources

An open science pathway for drug marketing authorization-Registered drug approval.

PLoS Medicine, 2021
Florian Naudet and co-authors propose a pathway involving registered criteria for evaluation and approval of new drugs.
Florian Naudet, Maximilian Siebert, Rémy Boussageon, Ioana A Cristea, Erick H Turner   +4 more
doaj   +2 more sources

The Impact of Label Changes (Boxed Warning) on Real-World Febuxostat Utilization in Patients with Gout: A Cross-Sectional Drug Utilization Study

Rheumatology and Therapy, 2023
Introduction This drug utilization study evaluated the impact of 2019 label changes on real-world febuxostat utilization among patients with gout. We describe the numbers and proportions of patients initiating febuxostat as new users (allopurinol-naïve ...
Alexandra Z. Sosinsky, Yufei Song, Lhanoo Gunawardhana, Syd Phillips, Matt Page   +4 more
doaj   +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

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, Rick A. Vreman, Hubert G. M. Leufkens, Aaron S. Kesselheim   +3 more
doaj   +1 more source

Drugs and Devices

JACC: Basic to Translational Science, 2016
The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj   +1 more source

Drugs, Devices, and the FDA: Part 1

JACC: Basic to Translational Science, 2016
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj   +1 more source

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America

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, Rick A. Vreman, Lawrence Liberti, Mario Alanis Garza   +3 more
doaj   +1 more source

Orphan Drug Approval in Canada, 1999-2022: A Cross-sectional Study [PDF]

International Journal of Health Policy and Management
The number of drugs for orphan indications has been increasing significantly in Canada and the federal government recently announced an investment of $1.5 billion dollars over 3 years primarily directed at helping to fund the cost of these drugs.
Joel Lexchin
doaj   +1 more source

Pharmacists’ Knowledge and Perceptions of FDA Approval Standards and the Breakthrough Therapy Designation

Pharmacy, 2022
The “breakthrough therapy” designation (BTD) is a recent mechanism implemented by the United States Food and Drug Administration (FDA) to expedite access to drugs that address unmet needs.
Megan C. Herink, Kirbee Johnston, Kristin Breninger, Erin Wu, Adriane N. Irwin   +4 more
doaj   +1 more source