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An Orphan Drug Legislation System
2015Orphan drugs are a treatment for rare diseases. From that, comes the importance of orphan drug development and discovery. For an orphan drug to be approved by the FDA, it does not have to be similar to any approved orphan drug. So chemists opinions are important to determine the probability of similarity.
Ahmed Abdelaziz +5 more
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The Food and Drug Legislation of 1906
Molecular Interventions, 2008Pray for the welfare of government; since were it not for the fear of government; men would swallow each other alive.
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Veterinary Nursing Journal, 2008
(2008). Controlled drug legislation. Veterinary Nursing Journal: Vol. 23, No. 1, pp. 19-20.
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(2008). Controlled drug legislation. Veterinary Nursing Journal: Vol. 23, No. 1, pp. 19-20.
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The Finnish legislation on workplace drug testing
Forensic Science International, 2008In Finland, the Act on the Protection of Privacy in Working Life (759/2004) that entered into force in 2004 incorporates provisions related to drug use testing, e.g. on the employers' right to process in certain situations information on job applicants' and employees' drug use.
Matti E, Lamberg +5 more
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Forthcoming changes in the misuse of drugs legislation
Veterinary Record, 1986The effects of the new regulations on veterinary practice are minimal. Veterinarians are mainly concerned with drugs in schedules 2 and 3 to the regulations and the requirements relating to these drugs are virtually unchanged. Pentazocine (Fortral) has been added to schedule 3 and from April 1, 1986, veterinarians must comply with the following ...
B R, Edwards, A, Knifton
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Generic legislation of new psychoactive drugs
Journal of Psychopharmacology, 2013New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs.
van Amsterdam, J +2 more
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Toward new legislation on drugs in Europe
Expert Review of Pharmacoeconomics & Outcomes Research, 2002Everybody acknowledges the merits of the European Medicines Evaluation Agency and the progress the European system has permitted in evaluating and approving medicinal products. Nevertheless, the system established in 1995 is ripe for updating and improvement in the light of experience.
Silvio, Garattini, Vittorio, Bertele'
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The New Medicare Prescription-Drug Legislation
New England Journal of Medicine, 2004In terms of dollars, the number of people affected, and the political stakes involved, the Medicare prescription-drug bill is the most important health care legislation passed by Congress since the enactment of Medicare and Medicaid in 1965. The six-month roller-coaster ride taken by the legislation made its passage all the more dramatic and surprising.
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Recent Drug Legislation in the United States
Postgraduate Medicine, 1965It is now apparent that the 1962 amendments to the Federal Food, Drug, and Cosmetic Act represent a substantial improvement in legal control over therapeutically useful but potentially hazardous drugs. Amendments relating to drugs require establishing the effectiveness of new drugs, progress reports on clinical investigations, accurate labeling ...
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No comparative drug efficacy without legislation
BMJ, 2011Data on the comparative efficacy of drugs—or relative efficacy, as it is termed in the EU1—are certainly needed.2 Apart from the pitfalls addressed by Sorenson and colleagues,2 the political reality is that comparative efficacy is required for national reimbursement decisions, which, not surprisingly, are fiercely defended by member states. In 2009 the
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