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Academic Journals
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From:Science (Vol. 227) Peer-ReviewedSix months ago, the Reagan Administration appointed Frank E. Young, dean of the University of Rochester medical school, to be commissioner of the Food and Drug Administration (FDA), which has broad authority over the...
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From:Oncology (Vol. 21, Issue 9) Peer-ReviewedGPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) recommended (12-0) that the FDA should wait for the final survival analysis of the SPARC trial...
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From:Future Virology (Vol. 8, Issue 4)Author(s): Sabrina Wai-Chi To 1 , Jonathan Hon-Kwan Chen 1 , Wing-Cheong Yam [*] 2 Keywords * determination; drug resistance monitoring; HIV-1 diagnostic assays; tropism; ultradeep sequencing; viral load...
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From:Future Virology (Vol. 8, Issue 12)Author(s): Lynn A Paxton 1 Keywords * emtricitabine; HIV; HIV prevention; PrEP; tenofovir Despite remarkable advances in the fields of HIV treatment and prevention in the past decade, the most recent UNAIDS...
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From:Nature Biotechnology (Vol. 33, Issue 1) Peer-ReviewedThe US Food and Drug Administration (FDA) has granted Pfizer subsidiary Wyeth Pharmaceuticals approval of its Trumenba vaccine for the prevention of meningococcal disease caused by Neisseria meningitidis serogroup B in...
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From:The Practitioner (Vol. 256, Issue 1750) Peer-ReviewedA comparative study using data from the US Food and Drug Administration (FDA) has found that the risk of depression and suicidal/self-harm behaviour is substantially greater with varenicline than with other smoking...
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From:Neurology India (Vol. 59, Issue 1) Peer-ReviewedByline: Gagandeep. Singh An adverse drug reaction (ADR) is defined by the World Health Organization as a noxious, unintended, and undesired drug effect, when used for therapeutic purposes in humans. ADRs to...
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From:Regulation (Vol. 34, Issue 2)* "Earning Exclusivity: Generic Drug Incentives and the Hatch-Waxman Act," by C. Scott Hemphill and Mark A. Lemley. January 2011. SSRN #1736822. Under provisions of the Hatch-Waxman Act, the first generic drug...
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From:Chemical Engineering (Vol. 117, Issue 1) Peer-ReviewedA device for the mass production of lactic acid oligomers, polylactic acid (PLA) and other polymers has been developed by Japanese researchers from the Renewable Plastics Group of the Research Institute for Innovation...
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From:Family Practice News (Vol. 39, Issue 18)The Food and Drug Administration issued its first-ever draft guidance for pharmaceutical manufacturers on how to develop a Risk Evaluation and Mitigation Strategy, which the agency increasingly requires of newly...
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From:Aging Health (Vol. 6, Issue 5) Peer-ReviewedAuthor(s): Veena K Ranganath 1 , Sogol Amjadi 1 , Edmond Melikterminas 1 , Daniel E Furst [[dagger]] 2 Keywords: Keywords * aging; biologics; comorbidities; DMARDs; older onset rheumatoid arthritis; rheumatoid...
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From:Aging Health (Vol. 7, Issue 3) Peer-ReviewedAuthor(s): Kelly M Makino 1 , Anton P Porsteinsson [[dagger]â ] 1 Keywords *⢠Alzheimer'âs disease; dementia; extended-release memantine; glutamate; N-methyl-D-aspartate Alzheimer'âs disease (AD) is a...
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From:Pharmaceutical Technology Europe (Vol. 20, Issue 9) Peer-ReviewedFurther details have emerged regarding the agreement for improved collaboration between FDA and EMEA. The cooperation will focus on four areas: quality and inspection, pharmacovigilance, scientific collaboration and...
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From:Family Practice News (Vol. 37, Issue 6)The Food and Drug Administration has upgraded the pregnancy risk category for NovoLog insulin from category C to B, based on the results of a large multinational study of pregnant women with type 1 diabetes. The...
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From:Pharmaceutical Technology Europe (Vol. 17, Issue 4) Peer-ReviewedAnalysis results of FDA warning letters regarding drugs, biologics and APIs sent out to pharmaceutical manufacturers in fiscal year 2004 has thrown up some surprises. There were a large number of violations of...
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From:Aging Health (Vol. 1, Issue 1) Peer-ReviewedAuthor(s): Lon S Schneider 1 Keywords : Alzheimer's disease; atypical antipsychotics; clinical trials; dementia; risperidone The diagnostic criteria for Alzheimer's disease (AD) requires the presence of...
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From:Environmental Health Perspectives (Vol. 112, Issue 12) Peer-ReviewedEarly identification of toxicologic side effects of a drug candidate is critical to an efficient drug discovery and development process. Toxicogenomics, the marriage of data-rich genomics approaches with traditional...
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From:Environmental Health Perspectives (Vol. 109, Issue 7) Peer-ReviewedThere are serious deficiencies in a program intended to ensure the safety of seafood sold in the United States, according to a January 2001 report issued by the General Accounting Office (GAO). Food Safety: Federal...
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From:Journal of Environmental Health (Vol. 63, Issue 7) Peer-Reviewed[less than]http://www.profoodsafety.org[greater than] Developed by the Iowa Department of Inspections and Appeals (DIA) through a $43,390 grant from the U.S. Food and Drug Administration (FDA), the Integrated Food...
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From:Pharmaceutical Technology Europe (Vol. 14, Issue 3) Peer-ReviewedRisk management is in the spotlight at the US FOOD AND DRUG ADMINISTRATION (FDA) as the need to gain more control over how drugs are used in medical practice becomes a major goal. The agency is reorganizing its staff...