An inspector checks ampules for extraneous matte on a plant's inpection line.  in 1969 FDA proposed the first major GMP revisions since 1963.

In December 1969, a Departmental study known as the Malek Report recommended a major reorganization of FDA along products lines. Indeed, the Bureaus of Compliance, Medicine, and Science soon were replaced by the Bureau of Drugs and the Bureau of Foods, Pesticides and Product Safety. To form the Bureau of Drugs, the drug and device activities of the Bureau of Medicine were combined with the pharmaceutical science responsibilities of the Bureau of Science and the drug and device compliance activities from the Associate Commissioner for Science. The new Bureau of Drugs consisted of four Offices: New Drugs, Marketed Drugs, Compliance, and Pharmaceutical Sciences.