FDA Rules "Violated By 10% Of research"

The US Food and Drug Administration's Bioresearch monitoring Program found serious violations of clinical research investigations for drugs and medical devices in only 10% of inspections in the fiscal year to September 30, 1995, despite a threefold rise in the number of inspections, the Food and Drug Inspection Monitor reports.

The FDA classified only 10% of clinical investigator inspections as "official action indicated" out of 709 inspections of researchers. OAI means the researchers could be barred from doing human testing with drugs, vaccines and medical devices.

However, inspections of individual researchers, contract research organizations, animal/toxicity labs and institutional review boards increased 34% in fiscal 1995 compared with the previous year. The number of hours devoted by the FDA to investigating the biomedical community rose 56% to 83,471 in the period, from 53,488, reports the journal.