![]() ![]() In the Federal Register of ( 69 FR 25527), FDA published a proposed rule that proposed to define “mode of action” (MOA) and “primary mode of action” (PMOA) (the proposed rule). End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: I. ![]() Leigh Hayes, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 30. Start Further Info FOR FURTHER INFORMATION CONTACT: The regulation is effective November 23, 2005. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. The Food and Drug Administration (FDA) is amending its combination product regulations to define “mode of action” (MOA) and “primary mode of action” (PMOA). The Rationale Behind This Final Ruleįood and Drug Administration, HHS. Application of Regulatory Authorities in the Review of Combination Products Comments on the Proposed Rule and FDA's Responses What are “Mode of Action” and “Primary Mode of Action?” Stakeholder Input Prior to Proposed Rulemaking This repetition of headings to form internal navigation links ![]() Headings within the legal text of Federal Register documents. This table of contents is a navigational tool, processed from the Provide legal notice to the public or judicial notice to the courts. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. ![]()
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