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 2016_register executive 2018-02-14 article Notices D09002ee1c7f32725 D09002ee1c7f327c1 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 Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of PMRs and PMCs is available on FDA's Web site.\1\ --------------------------------------------------------------------------- 81 FR 85573 https://www.govinfo.gov/app/details/FR-2016-11-28/2016-28442 2016-28442 fr28no16-68 4164-01-P Docket No. FDA-2016-N-3083 https://www.govinfo.gov/app/details/FR-2016-11-28/2016-28442 https://www.govinfo.gov/content/pkg/FR-2016-11-28/html/2016-28442.htm https://www.govinfo.gov/content/pkg/FR-2016-11-28/pdf/2016-28442.pdf 7 p. 85573 85579 81 FR 85573 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Federal Register Vol. 81, Issue NOTICE 2016-28442 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-N-3083 4164-01-P 2016-28442 Notice of availability.

Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of PMRs and PMCs is available on FDA's Web site.\1\ ---------------------------------------------------------------------------

Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Report on Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability , http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm https://www.gpo.gov/fdsys/pkg/FR-2016-10-31/html/2016-26247.htm Vol. 81, no. 228 Office of the Federal Register, National Archives and Records Administration 2016-11-28 continuing daily deposited born digital 446 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-11-28 P0b002ee1986802ab 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28no16 https://www.govinfo.gov/app/details/FR-2016-11-28 https://www.govinfo.gov/content/pkg/FR-2016-11-28/pdf/FR-2016-11-28.pdf https://www.govinfo.gov/content/pkg/FR-2016-11-28/xml/FR-2016-11-28.xml fdlp 85401 85835 DGPO 2018-02-14 2024-06-01 FR-2016-11-28 machine generated eng FR FR-2016-11-28 81 228