period of 5 years. Any person with an approved or pending drug product application who knowingly uses the services of Mr. Feuer in any in any capacity during his period of debarment will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Feuer, during his period of debarment, provides services in any capacity to a person with an approved or pending...

Critical to the successful implementation of a national medicines strategy is evaluation of the policy and ongoing monitoring of medicine use. Methods for monitoring medicines use within countries vary depending on the country and its stage of medicines policy development and implementation. In this paper, we provide four case studies on monitoring medicines use to support national medicines po...

I. History of medicines regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 II. Why regulating drugs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 III. What is medicines regulation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 IV. Drug registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...

OBJECTIVE Differences between women and men in political and economic empowerment, education, and health risks are well-documented. Similar gender inequities in access to care and medicines have been hypothesized but evidence is lacking. METHODS We analyzed 2002 World Health Survey data for 257,922 adult respondents and 80,932 children less than 5 years old from 53 mostly low and middle-incom...

Over the last decades, most countries have indeed acceded to at least one global or regional covenant confirming the right to health (1). The right to health should be achieved, among others, by making essential medicines of assured quality at an affordable price (2). but in this respect, a significant gap exists today between the majority of high-income countries, where the state has sufficien...