Drug Approval

Publication Title: 
CNS drugs

Evidence-based medicine (EBM) is a broad concept, but the key elements include the incorporation of clinical judgment (which requires clinical experience) together with relevant scientific evidence while remaining mindful of the individual patient's values and preferences.

Author(s): 
Citrome, Leslie
Publication Title: 
Wiener Medizinische Wochenschrift (1946)

Despite ongoing controversy, homeopathy has become increasingly accepted as a "medical reality" by patients and doctors alike. This process has been accompanied by an increased quality of manufacturing, education, research, and regulation of homeopathy. This paper argues that European regulation may now have gone too far by indiscriminately prescribing that homeopathic medicines should be used in a potency of D4 and higher. Low potencies and tinctures are an important and integral part of the homeopathic heritage.

Author(s): 
Van Haselen, Robbert
Publication Title: 
Trends in Pharmacological Sciences

Health problems are rising worldwide, be it as a consequence of lifestyle and longevity in increasingly affluent societies or due to a sharp rise in bacterial antibiotic resistance. The pharmaceutical industry is caught between high rates of attrition and the rather slow pace of a historically large regulatory system for pharmacological safety. Meanwhile, the past decade has seen a tremendous evolution of the biological toolbox, most notably of cellular assays, stem-cell differentiation and organ-mimicking systems. These systems were readily adapted for lead-compound identification.

Author(s): 
Tralau, Tewes
Luch, Andreas
Publication Title: 
Tropical medicine & international health: TM & IH

The synergistic antifolate combination of chlorproguanil with dapsone (CPG-DDS; LAPDAP) is being developed by a public-private partnership as a low-cost treatment for uncomplicated falciparum malaria. LAPDAP is rapidly eliminated from the body, giving it low selection pressure for drug resistance. Clinical cases with sulphadoxine-pyrimethamine (SP)-resistant infections acquired in Africa have been predicted to be responsive to LAPDAP, and clinical evidence is available to support this.

Author(s): 
Winstanley, P.
Publication Title: 
Cell

Traditional medicines provide fertile ground for modern drug development, but first they must pass along a pathway of discovery, isolation, and mechanistic studies before eventual deployment in the clinic. Here, we highlight the challenges along this route, focusing on the compounds artemisinin, triptolide, celastrol, capsaicin, and curcumin.

Author(s): 
Corson, Timothy W.
Crews, Craig M.
Publication Title: 
Malaria Journal

BACKGROUND: This case study describes how a public-private partnership between Medicines for Malaria Venture (MMV) and Sigma-Tau Industrie Farmaceutiche Riunite SpA achieved international regulatory approval for use of the fixed-dose artemisinin-based combination therapy dihydroartemisinin-piperaquine (Eurartesim®) for the treatment of malaria, enabling more widespread access to the medicine in malaria-endemic countries.

Author(s): 
Ubben, David
Poll, Elizabeth M.
Publication Title: 
Medicine and Law

Naturopathy has received considerable interest all over the world recently. The use of its methods and its consequences have raised legal and ethical problems. This article reports on the use of two 'oncolytic' drugs. Neither of them was produced by cancer researchers and neither passed the analytic examination required in pharmaceutical research. During their use--they were prescribed and applied by physicians--conventional treatment was withdrawn. The ethical responsibility of doctors using fringe medicine drugs is dealt with.

Author(s): 
Somogyi, E.
Publication Title: 
The Western Journal of Medicine

Although many clinical studies suggest the medical utility of marijuana for some conditions, the scientific evidence is weak. Many patients in California are self-medicating with marijuana, and physicians need data to assess the risks and benefits. The only reasonable solution to this problem is to encourage research on the medical effects of marijuana. The current regulatory system should be modified to remove barriers to clinical research with marijuana.

Author(s): 
Marmor, J. B.
Publication Title: 
Drug and Alcohol Dependence

The use of smoked marijuana as a therapeutic agent is presently a matter of considerable debate in the United States. Many people suffering from a variety of disorders maintain that it is necessary for their adequate treatment. Yet, the evidence to support claims is insufficient for FDA approval. An interim solution is proposed which would allow patients referred by their physicians to participate in a 6-month program of legal marijuana availability, similar to the 'compassionate IND' program of a number of years ago.

Author(s): 
Hollister, L. E.
Publication Title: 
California Law Review

The Supreme Court's recent decisions in United States v. Lopez and United States v. Morrison articulate a vision of federalism under which Congress's regulatory authority under the Commerce Clause is severely limited in favor of returning traditional areas of state concern, particularly criminal law enforcement, to local or state control. The Court's decisions in these cases coincide with ballot initiatives legalizing the medical use of marijuana garnering a majority of the vote in California, Arizona, Alaska, Colorado, Nevada, Oregon, Washington, Maine, and Washington D.C.

Author(s): 
Newbern, A. E.

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