Industry Best Practices

BIO supports the Agency's efforts to fully utilize new electronic health care data sources for post-approval pharmacoepidemiologic studies. These new data resources offer great promise to revolutionize the practice of pharmacovigilance with more timely and cost-effective methods for conducting post-market studies, but great care must be taken to minimize the potential for confounding and bias. We hope the Draft Guidance will provide additional transparency in scientific exchange between FDA and Sponsors when initiating appropriate pharmacoepidemiological studies in a regulatory context. With this goal in mind, we request clarification of several aspects of the Draft Guidance, particularly around the process for submitting and reviewing study protocols.

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Good Importer Practices. This guidance provides a useful quality systems framework for importers across all FDA-regulated industries to promote the safety of imported products. Biotechnology companies are currently leading significant efforts to further enhance the safety and security of biopharmaceuticals at every step of the supply chain and we encourage the FDA to minimize the potential for divergence between this guidance and current drug and biologic Good Manufacturing Practices regulations.