A few quick things to know about the Unified Agenda
- The Unified Agenda is updated twice per year, with editions known as the “Spring” and “Fall” editions. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.
- FDA’s agenda is generally consistent from edition to edition, with each edition consisting primarily of holdovers from previous editions.
- The latest Spring 2024 Unified Agenda contains 53 regulations that FDA plans to publish related to human medical product regulation. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.
A closer look at the seven new proposed regulations
| Stage of Rulemaking | Title | Estimated Publication | Synopsis |
| Proposed Rule | Amendments to the Current Good Manufacturing Practice Regulations for Drug Products | February 2025 | FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures. |
| Proposed Rule | Pediatric Study Plan Requirements for New Drug and Biologics License Applications | October 2024 | FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This proposed rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements. |
| Proposed Rule | Rulemaking to Provide by Regulation that an Ingredient Is Not Excluded From the Dietary Supplement Definition | December 2024 | This proposed rule, if finalized, would allow a specific ingredient to be marketed in or as a dietary supplement. Accordingly, products containing this ingredient could be lawfully marketed as dietary supplements, provided they otherwise meet the definition of “dietary supplement” under section 201(ff) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are not otherwise in violation of the FD&C Act. Section 201(ff) of the FD&C Act authorizes FDA, in its discretion, to issue a rule after notice and comment, finding that the article would be lawful” under the FD&C Act. |
| Proposed Rule | Radiology Devices; Classification of Blood Irradiator Devices | April 2024 | FDA is proposing to classify two types of blood irradiators, which are unclassified preamendments devices, based on intended use. Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III. |
| Proposed Rule | Drug Establishment Registration Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments | December 2024 | The proposed rulemaking will revise the registration regulations at 21 CFR 207 to: (1) Clarify that the drug establishment registration and drug listing requirements are applicable to foreign drug manufacturing establishments that do not directly import or offer for import drugs into the United States, but are still involved in the manufacture of drugs that are imported or offered for import into the United States following the passage of section 2511 of the PREVENT Pandemics Act; and (2) establish drug establishment registration requirements specific to establishments engaging in distributed manufacturing. |
| Proposed Rule | Sterility Requirements for Ophthalmic Preparations | September 2024 | The proposed rulemaking will revise 21 CFR 200.50 (Ophthalmic preparations and Dispensers) and 21 CFR 800.10 (Contact lens solutions; sterility) to (1) Remove historical and outdated language; (2) clarify the sterility requirements for ophthalmic preparations; and (3) establish additional requirements to ensure the safety of ophthalmic preparations packed in multiple-dose containers. |
| Final Rule | Amendments to Regulatory Hearing Before the Food and Drug Administration | September 2024 | FDA is issuing a direct final rule to amend the Scope section of our regulation that provides for a regulatory hearing before the Agency (21 CFR Part 16). This rule revises the list of statutory provisions enumerated in section 16.1(b)(1) by replacing one statutory reference with a different statutory reference under the same section of the same statute. |
Perhaps the most important changes to FDA’s agenda relate to updates regarding when certain major rules are expected to be released
- The next few months of anticipated FDA rulemaking do not contain much that would be considered controversial to most segments of the life sciences sector. This makes a certain amount of sense, as there is a Presidential election coming up in November 2024 and any controversial rules would likely be overturned if there is a change in administration. In addition, regulations passed in the last few months of a President’s term may be overturned under the Congressional Review Act, when certain other criteria are met.
- There are just a handful of major rules set to be released between now and the end of the calendar year. These include a new proposed rule on sterility requirements for ophthalmic preparations, and in particular additional requirements for preparations packed in multiple-dose containers; a proposed rule to enhance FDA’s ability to verify the reliability of data from bioequivalence and bioavailability studies; new “Good Importing Practice” requirements for drug companies; new requirements for submitting required initial pediatric study plans; the finalization of FDA’s Additional Conditions for Nonprescription Use (ACNU) rule; a final rule modifying the National Drug Code (NDC) format, and more.
- It’s worth noting that this agenda is susceptible to disruption if the upcoming election results in a change in Presidential administration. Former President Donald Trump has pledged to re-instate an executive order requiring the removal of two regulations for each new regulation promulgated by a federal agency.
- It’s also interesting to see what isn’t on this list. For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. The agency has come under fire from the bill’s sponsors for its inaction on this topic.
- An important note: The FDA is often under no obligation to publish regulations in accordance with this schedule, and long-term actions are often most susceptible to delays. Some rules are subject to statutory deadlines imposed by Congress, which often (though not always) compel the FDA to take timely action. Our list contains information about when a document was first included in the Unified Agenda, which is generally a good proxy for rules that have lingered on well past their initial target date.
- For proposed and final rules with near-term planned actions, the FDA is generally more likely to release regulations when it says it plans to. In our experience, FDA is most likely to release rules that it expects to publish in the next 6 months. Rules it expects to publish at the end of the year are often delayed unless there is a statutory deadline or an urgent need. Because the White House’s Office of Information and Regulatory Affairs (OIRA) must first review regulations before they can be released, the review process can also cause delays in the promulgation of a rule.
FDA’s agenda for human medical product regulation (in order of anticipated publication)
To contact the author of this analysis, please email Alec Gaffney ( agaffney@agencyiq.com).
To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com).