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FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

Posted 22 May 2015

FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week.

The announcement, contained in the latest edition of the US Unified Agenda, contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years.

FDA's latest update of the Unified contains two additional regulations compared to its last update in November 2014:

Rule StageRule TitleRINStatus
ProposedRegulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products0910-AF89New
FinalAmendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets; Implementation of Section 505(q) of the Federal Food, Drug, and Cosmetic Act0910-AG26Re-Added

According to FDA, its newly proposed rule on fixed-dose combinations (FDCs) and co-packaged products:

… would amend FDA regulations on fixed-combination prescription and over-the-counter (OTC) drugs. The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drug's claimed effects. The proposed rule would create a single set of regulations for prescription and OTC combination drugs, and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met. The proposed rule also would: Apply these regulations to combinations of biological drug products and to drug-biological product combinations; clarify application of FDA's requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs; establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product; and address the issue of co-packaging.

Its other rule, on Citizen Petitions, was previously introduced in 2012 as a proposed rule. It would implement Section 914 of the Food and Drug Administration Amendments Act, which governs Section 505(q) Citizen Petitions.


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