Results 51 to 60 of about 524,053 (116)
ADHD: Culture, Treatment Strategies and their Relevance to Preschool Children [PDF]
, 2010 In recent decades a growing number of individuals in preschool, middle childhood and adolescence have been diagnosed with ADHD. Accompanying increasing rates of diagnoses is an increase in the use of stimulant medication in preschool populations, a ...
Bean, Nelson M
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United States Food and Drug Administration and the Pharmaceutical Industry [PDF]
BMJ, 1961 openaire +2 more sources
FDA Enforcement and the Constitution: The Validity of FDA Seizures under the Due Process and Just Compensation Clauses [PDF]
, 2012 This paper explores the way in which enforcement actions by the Food and Drug Administration (FDA) interact with certain constitutional rights, and it queries whether the system does its most to protect those rights while preserving the public interest ...
Shane, Andrew L.
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The Potential Success of the F.D.A.’S New Paradigm Based on Community Pharmacists’ Opinons [PDF]
, 2014 For the past 40 years the F. D. A. (Food and Drug Administration) has considered creating a third class of drugs in the United States of America that would be a pharmacist-only class which could only be sold with the approval of a pharmacist.
Brown, Anna Blair
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cGMP Recombinant FIX for IV and Oral Hemophilia B Therapy [PDF]
, 2005 Three specific aims are proposed: Specific Aim # 1. Process engineer and scale-up the recovery and purification of transgenic recombinant human Factor IX.
Dernell, William, KEY PERSON +9 more
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What is the best treatment for oral thrush in healthy infants? [PDF]
, 2008 Nystatin oral suspension is a safe first-line therapy; fluconazole is more effective (strength of recommendation [SOR ]: B, 1 small randomized controlled trial [RCT]) but has not been approved by the Food and Drug Administration (FDA) for use in ...
Gaskie, Sean +2 more
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Is the Food and Drug Administration Safe and Effective? [PDF]
In the United States, drug safety and efficacy are primarily regulated by the Food and Drug Administration (FDA) and the legal system, which gives manufacturers large incentives to produce safe drugs and provide proper warnings for side effects, since ...
Eric Sun, Tomas J. Philipson
core
PharmaceuticsDrug development costs can be significantly reduced if proven “platform” technologies are allowed to be used without having to validate their use. The most recent US Food and Drug Administration (FDA) guideline brings more clarity, as well as a greater focus on the most complex technologies that can now be used for faster drug development.
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United States Food and Drug Administration Drug Approval Summary
Clinical Cancer Research, 2004Abstract On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies.
Martin H. Cohen +11 more
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Oncology drug development: United States Food and Drug Administration perspective
Critical Reviews in Oncology/Hematology, 2002The Food and Drug Administration (FDA) in the United States has multiple roles. The primary responsibilities for oncology drug products are the supervision of clinical research, the evaluation of marketing claims for new and previously approved drugs, the granting of exclusive marketing licenses for approved claims, and the monitoring of post-marketing
Steven, Hirschfeld, Richard, Pazdur
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