United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-02-25 article Notices D09002ee1c7fd5edf D09002ee1c7fd5f7c United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees. 77 FR 11553 https://www.govinfo.gov/app/details/FR-2012-02-27/2012-4427 2012-4427 fr27fe12-87 4160-01-P Docket No. FDA-2012-D-0080 https://www.govinfo.gov/app/details/FR-2012-02-27/2012-4427 https://www.govinfo.gov/content/pkg/FR-2012-02-27/html/2012-4427.htm https://www.govinfo.gov/content/pkg/FR-2012-02-27/pdf/2012-4427.pdf 2 p. 11553 11554 77 FR 11553 Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products-Questions and Answers; Availability; Federal Register Vol. 77, Issue NOTICE 2012-4427 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0080 4160-01-P 2012-4427 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "FDA Oversight of PET Drug Products--Questions and Answers." The draft guidance provides questions and answers that address nearly all aspects of the FDA approval and surveillance processes, including application submission, review, compliance with good manufacturing practices, inspections, registration and listing, and user fees.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 29, 2012. Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, rm. 6164, Silver Spring, MD 20993-0002, 301-796-3416. Draft Guidance; Availability: Oversight of Positron Emission Tomography Drug Products , http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 77, no. 38 Office of the Federal Register, National Archives and Records Administration 2012-02-27 continuing daily deposited born digital 364 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-02-27 P0b002ee181f32783 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27fe12 https://www.govinfo.gov/app/details/FR-2012-02-27 https://www.govinfo.gov/content/pkg/FR-2012-02-27/pdf/FR-2012-02-27.pdf https://www.govinfo.gov/content/pkg/FR-2012-02-27/xml/FR-2012-02-27.xml fdlp 11383 11735 DGPO 2012-02-25 2024-06-03 FR-2012-02-27 machine generated eng FR FR-2012-02-27 77 38