The agency-wide Bioresearch Monitoring Program was initiated in 1977. Its goals are to
ensure the integrity of preclinical and clinical data submitted in support of applications for …

This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses
on the inspection of clinical investigators who study investigational drugs. The differences …

BEFORE a new drug may enter the market in the United States, evidence for its safety and
effectiveness for proposed use or uses must be presented to and approved by the Food and …

On September 27, 1977, The Federal Register published the first of a series of proposed
new regulations by the Food and Drug Administration on bio‐research monitoring. The …

As part of the Food and Drug Administration's (FDA's) Bioresearch Monitoring Program,
clinical studies are inspected to monitor the conduct of research involving investigational …

Well-founded pharmacokinetic information is one of the cornerstones of a New Drug
Application (NDA) to the Food and Drug Administration (FDA) required to introduce a new …

Since 1962, when the Food and Drug Administration was given broad power to regulate
investigations of new drugs, several major regulatory themes have emerged. First, the FDA …

The Bioresearch Monitoring Program (BiMo) is an agency-wide pro gram introduced in
1977. Its purpose is to ensure the quality and integrity of data submitted to the agency in …

The Food and Drug Administration has been conducting audits of the work of clinical
investigators since 1962, and has done so on a routine basis since 1977. Since 1977 the …

The Good Laboratory Practice (GLP) regulations of the US Food and Drug
Administration'were promulgated to assure the quality and integrity of nonclinical laboratory …