Paper marketed drugs

Macoun, Robert, and Peter Reuter. Cross-National Drug Policy. Annals of the American Academy of Political and Social Science, vol. 582, July 2002. Thousand Oaks, Calif. SAGE Publications, 2002. This volume is a collection of papers on drug policy issues in many nations. Topics discussed include drug law enforcement, harm minimization, and legalization, as well as the economic, social, and political aspects of black markets in illegal drugs in Colombia, Iran, and Russia. 

The vast bulk of prescription drugs on the market today are subject to the requirement for some form of an approved NDA. Following enactment of the Drug Price Competition and Patent Term Restoration Act of 1984, there are now three clearly established types of NDA a full NDA, a paper NDA [now called a Section 505(b)(2) NDA, after the provision in the FD C Act that created it], and an abbreviated NDA. Each of these is discussed in the sections that follow. 

Lichtenberg, F., and J. Waldfogel. 2003. Does Misery Love Company Evidence from Pharmaceutical Markets before and after the Orphan Drug Act. National Bureau of Economic Research Working Paper 9750. 

The popularity of botanical products in the United States is reflected in a survey on complementary and alternative medicine that showed that American consumers had spent an estimated 5.1 billion on botanical products in 1997 (1). In the same year, the global market for botanical medicinal products was estimated to be approximately 20 billion (2,3). It has been estimated that currently more than 1500 botanical products are available in the U.S. market alone (4). This popularity has been fueled, in part, by the perception that botanicals are naturally derived products, and hence are safe and devoid of adverse effects. This perception appeared to be justified by a paper summarizing the fatality of pharmaceutical drugs and botanical products in the 1981-1993 period, in which statistics compiled by the National Center for Health Statistics, the American Association of Poison Control Centers, Centers for Disease Control and Prevention, the Journal of the American Medical Association, and the U.S. Consumer Product Safety Commission showed an annual mortality rate of 100,000 deaths... 

Since there has been disagreement over the meaning of the terms safe and effective, this paper will use new chemical entities (NCE s) approved for marketing by FDA as the measure for drug innovation — the more approved NCE s per R D dollar, the more productive drug research is, if one accepts this definition. It appears to be a commonly accepted definition (1). 

The only other part of the proposed Act bearing a direct relationship to the discussion in this paper is the provision setting forth conditions under which a drug product not approved for marketing in the United States may be exported (see T6 and 7 for more detail on the DRRA). 

Howlett D, Colwell J, Goldsmith S, McCallion ON. Correlation of extractables and leach -ables from marketed pMDIs. Paper presented at Respiratory Drug Delivery VIII, 2002. 

The paper focuses on the fact that the actual drug discovery activities are today a high-tech business but that the aforementioned three areas to bring the drug successfully to the market are still low... 

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