Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

OMB 0910-0409

This information collection supports agency regulations at 21 CFR 315.4, 315.5, and 315.6. The regulations require manufacturers of diagnostic radiopharmaceuticals to submit certain information demonstrating safety and effectiveness of these products.

The latest form for Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring expires 2021-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0409 in vivo Pharmaceuticals SSA 2024 EXT.docx Supporting Statement A
In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

All Historical Document Collections

202403-0910-007	Extension without change of a currently approved collection	2024-03-21
202103-0910-004 Approved without change	Extension without change of a currently approved collection	2021-04-14
201804-0910-006 Approved without change	Extension without change of a currently approved collection	2018-04-11
201501-0910-002 Approved without change	Extension without change of a currently approved collection	2015-01-08
201110-0910-003 Approved without change	Extension without change of a currently approved collection	2011-10-05
200810-0910-001 Approved without change	Extension without change of a currently approved collection	2008-10-08
200508-0910-002 Approved without change	Revision of a currently approved collection	2005-08-19
200207-0910-005 Approved without change	Extension without change of a currently approved collection	2002-07-30
199905-0910-009 Approved without change	New collection (Request for a new OMB Control Number)	1999-05-20