New FDA guidelines for anti-infective drugs

Abstract

The 1977 Guidelines for the Evaluation of Anti-infective Drug Products are no longer useful. The IDSA has established a contract with the FDA to revise and update these documents. Thirteen sub-committees will address specific areas of infectious diseases. A general guideline will also be written that proposes modification of the drug evaluation process. The documents will be reviewed by specialist in infectious diseases and clinical microbiology working in practice, academic medicine, the pharmaceutical industry, and the FDA. A second series of draft documents will be prepared and reviewed again, with final approval provided by the FDA. Current plans call for presentation of these guidelines to FDA Advisory Committees in November 1990. Publication of most or all of these guidelines is the primary objective of the contract. If successful, the process may be used to develop guidelines for the evaluation of other classes of drugs, medical devices, and biologic products.