Raising suspicions with the Food and Drug Administration: detecting misconduct.

The clinical Bioresearch Monitoring (BIMO) oversight program of the US Food and Drug Administration (FDA) assesses the quality and integrity of data submitted to the FDA for new product approvals and human subjects protection during clinical studies. A comprehensive program of on-site inspections and data verification, the BIMO program routinely performs random inspections to verify studies submitted to the FDA to support a marketing application. On occasion the FDA will conduct a directed inspection of a specific site or study to look for problems that may have previously been identified.

Hepatomegaly with severe steatosis in HIV-seropositive patients.

Objective: To describe death attributed to severe hepatomegaly and macrovesicular steatosis without inflammation or necrosis in HIV-seropositive patients without AIDS.

Patients: Patients from the AIDS Clinical Trials Group (ACTG) Adverse Reactions and the Food and Drug Administration's (FDA) Spontaneous Report databases.

Results: Six fatal and two non-fatal cases in which no known cause of hepatic steatosis could be found were identified.

Report of the New England Task Force on Reducing Heart Disease and Stroke Risk.

Five years ago, a task force on reducing risk for heart disease and stroke was established by the six New England States. The task force included representatives from State public health departments, academia, the corporate sector, and voluntary organizations. This article is the final report of the task force.

Bioequivalence of generic thioridazine drug products--the FDA viewpoint.

The phenothiazines are among the most widely used drugs to treat symptoms commonly associated with acute and chronic psychoses. One of the commonly prescribed compounds within this class of drugs is thioridazine, available both as a generic product as well as the innovator product, Mellaril. Each of these products is coded as bioequivalent and consequently therapeutically equivalent by the Food and Drug Administration (FDA).