Results 331 to 340 of about 5,566,486 (385)
Some of the next articles are maybe not open access.
Drug Information Journal, 1992
The Passport to Drug Approval in Europe will be changed in the future. The proposal of the Commission of the European Economic Community (EC) for the free movement of medicinal products in the future is discussed. After a short discussion of the proposal, information is given on the influence outside the EC, on what happens in the EC, and the influence
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The Passport to Drug Approval in Europe will be changed in the future. The proposal of the Commission of the European Economic Community (EC) for the free movement of medicinal products in the future is discussed. After a short discussion of the proposal, information is given on the influence outside the EC, on what happens in the EC, and the influence
openaire +2 more sources
Accelerating drug development and approval
Drug News & Perspectives, 2010Regulatory agencies are the gateway between the pharma/biotech industry and patients and can serve as stimulators of new drug development. This article highlights several means of doing so implemented thus far, many with already impressive histories, such as orphan drug legislation, and others of a more experimental nature, such as the FDA's priority ...
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Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.
Journal of the American Medical Association (JAMA)Importance The US Food and Drug Administration's (FDA) accelerated approval pathway allows approval of investigational drugs treating unmet medical needs based on changes to surrogate measures considered "reasonably likely" to predict clinical benefit ...
I. T. Liu, Aaron S. Kesselheim, E. Cliff
semanticscholar +1 more source
Real-world evidence and regulatory drug approval
Nature Reviews Clinical Oncology, 2020M. Raphael, B. Gyawali, C. Booth
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Antibody–drug conjugates: Smart chemotherapy delivery across tumor histologies
Ca-A Cancer Journal for Clinicians, 2022Paolo Tarantino +2 more
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Non-Approved Use of Food and Drug Administration Approved Drugs
American Journal of Ophthalmology, 1979Joseph I. Goldstein, Joel S. Mindel
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Cancer epigenetics in clinical practice
Ca-A Cancer Journal for Clinicians, 2023Veronica Davalos, Manel Esteller
exaly
Alnylam prepares to land first RNAi drug approval
Nature reviews. Drug discovery, 2018Chris Morrison
semanticscholar +1 more source