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 2003_register executive 2010-09-23 article Notices D09002ee1c817cdf0 D09002ee1c817ce55 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 required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's first report on the status of the study commitments that sponsors have agreed to conduct and for which an annual status report on the study has been received by FDA. 68 FR 27822 https://www.govinfo.gov/app/details/FR-2003-05-21/03-12720 03-12720 fr21my03-52 4160-01-S Docket No. 03N-0170 https://www.govinfo.gov/app/details/FR-2003-05-21/03-12720 https://www.govinfo.gov/content/pkg/FR-2003-05-21/html/03-12720.htm https://www.govinfo.gov/content/pkg/FR-2003-05-21/pdf/03-12720.pdf 2 p. 27822 27823 68 FR 27822 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability; Federal Register Vol. 68, Issue NOTICE 03-12720 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 03N-0170 4160-01-S 03-12720 Notice of availability.

The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's first report on the status of the study commitments that sponsors have agreed to conduct and for which an annual status report on the study has been received by FDA.

Kim Colangelo, Center for Drug Evaluation and Research (HFD-20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-3937; or Robert Yetter, Center for Biologics Evaluation and Research (HFM-25), 1400 Rockville Pike, Rockville, MD 20852, 301-827-0373. Reports and guidance documents; availability, etc.: FDA Modernization Act of 1997 Drug and biologics firms conducting postmarketing commitment studies; performance report, www.fda.gov/cder Vol. 68, no. 98 Office of the Federal Register, National Archives and Records Administration 2003-05-21 continuing daily deposited born digital 175 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2003-05-21 P0b002ee1809e316a 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21my03 https://www.govinfo.gov/app/details/FR-2003-05-21 https://www.govinfo.gov/content/pkg/FR-2003-05-21/pdf/FR-2003-05-21.pdf https://www.govinfo.gov/content/pkg/FR-2003-05-21/xml/FR-2003-05-21.xml fdlp 27727 27890 DGPO 2010-09-23 2024-06-07 FR-2003-05-21 machine generated eng FR FR-2003-05-21 68 98