FDA Releases Guidance on NDA, BLA Safety Reviews

The FDA has announced the availability of final guidance for industry on how to conduct a safety review of a new drug application (NDA) and a biologics license application (BLA).

Released as part of the agency's good review practice initiative, the guidance is intended to assist individuals conducting safety reviews as part of the NDA and BLA process, to provide standardization and consistency in the format and content of safety reviews, and to ensure that critical presentations and analyses will not be inadvertently omitted. The guidance was originally released in draft form in 1996.

The safety review has two distinct components: identifying the significance of the adverse events reported in clinical trials, and evaluating of the adequacy of the safety evaluation. The guidance describes an approach that integrates safety findings across all studies and other clinical experience, said the FDA.

The guidance is an expansion of Section 7 of the clinical review template and is compatible with that template, which was developed by the Center for Drug Evaluation and Research.

To view the guidance, "Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review," go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0057-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0057-gdl0001.pdf).