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 2009_register executive 2014-05-29 article Proposed Rules D09002ee1c80348a1 D09002ee1c803494e 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) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products. 74 FR 50744 https://www.govinfo.gov/app/details/FR-2009-10-01/E9-23519 E9-23519 FR01OC09-25 RIN 0910-AF82 4160-01-S Docket No. FDA-2008-N-0424 https://www.govinfo.gov/app/details/FR-2009-10-01/E9-23519 https://www.govinfo.gov/content/pkg/FR-2009-10-01/html/E9-23519.htm https://www.govinfo.gov/content/pkg/FR-2009-10-01/pdf/E9-23519.pdf Combination Products Biological Products Devices Drugs Human Cell Tissue Cellular and Tissue-Based Products Regulation of Combination Products 15 p. 50744 50758 74 FR 50744 Title 21 Part 4 21 CFR Part 4 RIN 0910-AF82 Postmarketing Safety Reporting for Combination Products; Federal Register Vol. 74, Issue PRORULE E9-23519 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2009-12-30 Docket No. FDA-2008-N-0424 4160-01-S E9-23519 Proposed rule.

The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

Submit written or electronic comments on the proposed rule by December 30, 2009. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the "Paperwork Reduction Act of 1995" section of this document). Leigh Hayes, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 301-427-1934. Combination Products Biological Products Devices Drugs Human Cell Tissue Cellular and Tissue-Based Products Regulation of Combination Products Postmarketing Safety Reporting for Combination Products, http://www.bls.gov/oes/current/naics4_325400.htm#b23-0000 http://www.regulations.gov Vol. 74, no. 189 Office of the Federal Register, National Archives and Records Administration 2009-10-01 continuing daily deposited born digital 251 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2009-10-01 P0b002ee1892c8d38 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR01OC09 https://www.govinfo.gov/app/details/FR-2009-10-01 https://www.govinfo.gov/content/pkg/FR-2009-10-01/pdf/FR-2009-10-01.pdf https://www.govinfo.gov/content/pkg/FR-2009-10-01/xml/FR-2009-10-01.xml fdlp 50671 50910 DGPO 2014-05-29 2024-06-04 FR-2009-10-01 machine generated eng FR FR-2009-10-01 74 189