FDA GOOD LAB PRACTICE PROPOSED REG REVISION ALLOWS PRODUCT CHARACTERIZATION AFTER INITIAL TOXICITY TESTS; CHANGES WOULD PROVIDE MORE FLEXIBILITY, FDA SAYS

FDA's Good Lab Practices (GLP) rewrite would allow for product characterization studies to be performed after initial toxicological tests have been completed, according to the agency's proposed revisions, published in the Oct. 29 Federal Register. In the notice, FDA pointed out that current regulations require product sponsors to fully characterize the test article "prior to initiating the first safety test in the toxicology profile." Product characterization consists of chemical tests to determine concentration, identity, Stability, limits of impurity, etc. FDA explained that the proposed change in the regulation "will permit the conduct of the characterization studies after the results of the initial toxicology studies are available. If these studies show unusual toxicity, and the product is dropped from further consideration, no characterization need be done." The agency said it has been informed that "the cost of test article characterization greatly exceeds the cost of conducting the initial safety studies that are done." In announcing the proposed GLP reg rewrite, FDA said that the revisions are intended "to reduce regulatory burdens on testing facilities" and to allow "greater flexibility in conducting nonclinical studies." Along with revisions in the timing of test and control article characterization, significant changes are proposed by the agency in sections of the regs dealing with quality assurance, protocol preparation, and retention of specimens and samples. Among the specific changes proposed in the rewrite are a modification of the requirement that the lab Quality Assurance Unit inspect each phase of a study at periodic intervals according to rigid schedules. The proposed changes, the agency said, will give the unit "reasonable leeway to identify critical study phases and to set reasonable inspection schedules so that studies can be monitored appropriately." GLP Streamlining Facilitated By High Compliance Levels Found In FDA Inspections Changes are also proposed in sections of the GLPs covering animal care and related facilities. Included are modifications of the requirements that separate areas for the diagnosis, treatment, and control of laboratory animal diseases be provided, and that new test animals be quarantined. Instead of strict "quarantining," FDA said that the rewrite would require "that newly received animals be isolated and that the health status of all newly received animals be evaluated in accordance with acceptable veterinary medical practice." The proposed GLP rewrite also would clarify that stability data need be collected only as necessary to accommodate the conditions of use of a test article mixture. FDA noted that "the revision makes it clear that although full long-term stability studies are not required, the term of the stability study may not be shorter than the actual term of use." FDA said it reevaluated the GLP regs and proposed the changes because of the "satisfactory levels of laboratory compliance observed during agency inspections; the information received from regulated laboratories identifyng particularly burdensome provisions of the GLPs; and the principles of regulatory reform." In determining that compliance levels were high, FDA reviewed over 700 laboratory inspections made since the Toxicology Laboratory Monitoring Program was established in 1976, the document said. The agency found a higher level of compliance than originally anticipated, which encouraged FDA streamline the regs.