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Hershel Jick, MD; Alexander M. Walker, MD, MPH; Claude Spriet-Pourra, MD

JAMA. 1979;242(21):2310-2314.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

THERE is a general but strongly held view that, after drugs are marketed, additional epidemiologic information is needed on their clinical effects, particularly adverse effects. This notion is based soundly on the limited size and scope of the clinical experience with a drug before marketing. Recently, considerable interest has been evident in this area and has focused on the term "postmarketing surveillance" (PMS). That the interest is widespread and intense is reflected in the many meetings that have taken place, articles that have been written, and committees that have been formed to consider the designing of large formal systems of PMS.^1-15 Given the diffuse nature of the subject, it is essential to take an objective and informed look at the legitimate needs in this area and to consider practical means of satisfying these needs. Without a clear understanding of the nature of the problems that can be addressed epidemiologically . . . [Full Text PDF of this Article]

Author Affiliations
From the Boston Collaborative Drug Surveillance Program, Boston University Medical Center (Drs Jick and Walker) and Department Médical, Laboratories Hoechst, Paris (Dr Spriet-Pourra).

Footnotes
Reprint requests to Boston Collaborative Drug Surveillance Program, 400 Totten Pond Rd, Waltham, MA 02154 (Dr Jick).

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