Results 1 to 10 of about 8,026 (196)

Adapting drug approval pathways for bacteriophage-based therapeutics [PDF]

Frontiers in Microbiology, 2016
The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long
Callum Cooper, Mohammadali Khan Mirzaei, Mohammadali Khan Mirzaei, Anders S Nilsson   +3 more
doaj   +2 more sources

From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt [PDF]

Pharmaceuticals
Pharmacogenomics (PGx) is the hope for the full optimization of drug therapy while minimizing the accompanying adverse drug events that cost billions of dollars annually.
Fadya M. Elgarhy, Abdallah Borham, Noha Alziny, Khlood R. AbdElaal, Mahmoud Shuaib, Abobaker Salem Musaibah, Mohamed Ali Hussein, Anwar Abdelnaser   +7 more
doaj   +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

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

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

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

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

Product Complexity and Strategic Alliance on Drug Approval

American Business Review, 2021
Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped relationship between product complexity and the time to approval by the US Food and Drug Administration (FDA)
Taoyong Su , Wanrong Hou , Edward Levitas , Sibin Wu   +3 more
doaj   +1 more source