This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Hunter, J. R. Articles by DeChristoforo, R. Search for Related Content Social Bookmarking                         What's this?

Overview of the Food and Drug Administration Procedures for Expediting the Development and Evaluation of Drugs for the Treatment of Acquired Immunodeficiency Syndrome and Other Life-Threatening Illnesses

US Food and Drug Administration, Rockville, Warren Avant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD

David L. Rosen

US Food and Drug Administration, Rockville, Warren Avant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD

Robert DeChristoforo

US Food and Drug Administration, Rockville, Warren Avant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD

The acquired immunodeficiency syndrome (AIDS) epidemic has focused increased attention on new drug development and the Food and Drug Administration (FDA) evaluation process for durgs to treat patients with AIDS and other severely debilitating or life-threatening illnesses. To expedite the review of these experimental drugs and to make them available to patients earlier in the development process, the FDA has implemented new procedures and mechanisms. In the new drug regulations, the subpart E procedures commit the FDA to extensive and intensive participation in the initial stages of development of these drugs. Early consultation by the FDA with drug sponsors, more frequent meetings between the FDA and drug sponsors, larger and more extensive phase 1 and phase 2 trials, and postmarketing surveillance are some of the key features of these FDA procedures. The subpart E procedures reflect the philosophy that early involvement by the FDA in drug study design enhances the likelihood that the results from these studies will provide enough information to allow the FDA to more quickly assess the safety and efficacy of these drugs. Treatment Investigational New Drug Applications (INDs) increase the early availability of experimental drugs in the final stages of the FDA evaluation process, but before final approval. Both the parallel track proposal and the accelerated drug approval concept are additional mechanisms intended to increase the early availability of drugs for patients with AIDS.

This is a US government work. There are no restrictions on its use.

Journal of Pharmacy Practice, Vol. 5, No. 3, 143-150 (1992)
DOI: 10.1177/089719009200500307


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?