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 2008_register executive 2010-09-23 article Notices D09002ee1c807fdcd D09002ee1c807ff49 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 concept paper entitled "PDUFA Pilot Project Proprietary Name Review." The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review under an anticipated pilot program. FDA plans to begin enrollment in the pilot program in fiscal year (FY) 2009. 73 FR 58604 https://www.govinfo.gov/app/details/FR-2008-10-07/E8-23715 E8-23715 fr07oc08-82 4160-01-S Docket No. FDA-2008-N-0281 https://www.govinfo.gov/app/details/FR-2008-10-07/E8-23715 https://www.govinfo.gov/content/pkg/FR-2008-10-07/html/E8-23715.htm https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/E8-23715.pdf 2 p. 58604 58605 73 FR 58604 Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Federal Register Vol. 73, Issue NOTICE E8-23715 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2008-N-0281 4160-01-S E8-23715 Notice; availability.

The Food and Drug Administration (FDA) is announcing the availability of a concept paper entitled "PDUFA Pilot Project Proprietary Name Review." The concept paper provides information to pharmaceutical firms about how to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review under an anticipated pilot program. FDA plans to begin enrollment in the pilot program in fiscal year (FY) 2009.

Submit written or electronic comments on the pilot program at any time. Lana Pauls, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg, 51, rm. 6196, Silver Spring, MD 20993, 301-796-0518, FAX: 301-847-8753, e-mail: lana.pauls@fda.hhs.gov, or Pilot Program To Evaluate Proposed Name Submissions; Concept Paper, lana.pauls@fda.hhs.gov http://www.fda.gov/cder/drug/MedErrors/meeting_2008.htm http://www.fda.gov/cder/meeting/drugNaming.htm http://www.fda.gov/ohrms/dockets/ac/cder03.html#DrugSafetyRiskManagement http://www.regulations.gov Vol. 73, no. 195 Office of the Federal Register, National Archives and Records Administration 2008-10-07 continuing daily deposited born digital 442 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2008-10-07 P0b002ee1809b4183 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07oc08 https://www.govinfo.gov/app/details/FR-2008-10-07 https://www.govinfo.gov/content/pkg/FR-2008-10-07/pdf/FR-2008-10-07.pdf https://www.govinfo.gov/content/pkg/FR-2008-10-07/xml/FR-2008-10-07.xml fdlp 58435 58866 DGPO 2010-09-23 2024-06-05 FR-2008-10-07 machine generated eng FR FR-2008-10-07 73 195