Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring; Extension of Comment Period

Resumo

The Food and Drug Administration (FDA) is extending to October 15, 1998, the comment period on a proposal rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). The document proposed to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The agency is taking this action to provide interested persons additional time to submit comments to FDA on the proposed rule.