Results 51 to 60 of about 4,498,317 (372)

Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016

open access: yesJAMA Network Open, 2020
Key Points Question What are the available data on cancer treatment outcomes for new cancer therapies approved by the US Food and Drug Administration?
Aviv Ladanie   +15 more
semanticscholar   +1 more source

A review of new drugs approved by the food and drug administration in 2022

open access: yesJournal of Family Medicine and Primary Care, 2023
Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan   +2 more
doaj   +1 more source

An Integrated System of Drug Matching and Abnormal Approval Number Correction [PDF]

open access: yesarXiv, 2022
This essay is based on the joint project with 111, Inc. The pharmacy e-Commerce business grows rapidly in recent years with the ever-increasing medical demand during the pandemic. A big challenge for online pharmacy platforms is drug product matching. The e-Commerce platform usually collects drug product information from multiple data sources such as ...
arxiv  

Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]

open access: yes, 2005
Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
core   +3 more sources

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017

open access: yesJAMA Network Open, 2020
Key Points Question Have the number and characteristics of pivotal efficacy trials supporting US Food and Drug Administration approval of new drugs and biologics changed during the past 3 decades?
A. Zhang   +5 more
semanticscholar   +1 more source

Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study

open access: yesJournal of Pharmaceutical Policy and Practice, 2017
Background The WHO Model List of Essential Medicines for Children (EMLc) covers medicines for globally high-burden diseases. Regulatory approval in high-income countries ensures evidence and dosage form but usually focuses on diseases common in those ...
Rumiko Shimazawa, Masayuki Ikeda
doaj   +1 more source

Knowledge-Driven New Drug Recommendation [PDF]

open access: yesarXiv, 2022
Drug recommendation assists doctors in prescribing personalized medications to patients based on their health conditions. Existing drug recommendation solutions adopt the supervised multi-label classification setup and only work with existing drugs with sufficient prescription data from many patients.
arxiv  

Slowing Down Accelerated Approval: Examining the Role of Industry Influence, Patient Advocacy Organizations, and Political Pressure on FDA Drug Approval [PDF]

open access: yes, 2022
The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA ...
Diu, Stephanie
core   +1 more source

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

open access: yesPharmaceuticals
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   +7 more
doaj   +1 more source

Pragmatic clinical trials in the context of regulation of medicines

open access: yesUpsala Journal of Medical Sciences, 2019
The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data.
Rolf Gedeborg   +3 more
doaj   +1 more source

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