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

Streszczenie

The Food and Drug Administration (FDA) is extending to November 16, 1998, the comment period on a proposed 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 for diagnosis and monitoring. The agency is taking this action to provide interested persons additional time to submit comments to FDA on the proposed rule.