Unified Agenda
Food and Drug Administration: 2026 Regulatory Agenda
Every rulemaking the FDA has on its regulatory agenda in the 2026 Unified Agenda. Proposed rules, final rules, and long-term actions, each with the agency's own summary and its latest status.
Source: the 2026 Regulatory Plan and Unified Agenda, published by OIRA on July 3, 2026 (reginfo.gov). The FDA lists 80 active actions plus 9 completed this cycle. Refreshed as the agenda changes.
Regulatory Plan marks the agency’s most significant planned actions, singled out by OIRA in the Regulatory Plan that accompanies this edition.
What changed since the Spring 2025 agenda
Between editions, the FDA added 26 new rules, changed the stage on 20, and dropped 6 from the agenda. The official agenda only shows you today’s snapshot. We keep the history, so you can see what actually moved.
- New this edition. Amendment and Revocation of Organizational Information Regulations (entered the Final Rule stage)
- Moved. Administrative Detention of Tobacco Products (Long-Term to Proposed Rule)
- Moved. Amendment to Records and Reports Concerning Adverse Drug Experiences on Marketed Prescription Drugs for Human Use Without Approved New Drug Applications (Long-Term to Proposed Rule)
and 49 more changes this edition, including 6 rules that dropped off the agenda entirely.
Track the FDA agenda freeSignificant, priority, and finalized rules are shown in full below. Routine actions are condensed to a line, with full summaries for every rule on the dashboard.
Slated for a final rule. Several have already published in the Federal Register, which we mark on each; the rest are still pending.
Front-of-Package Nutrition Labeling
This rule, if finalized, would require the front of food labels to display certain nutrition information to help consumers, including those who are busy and those with lower nutrition knowledge, make more informed dietary choices. Front-of-package nutrition labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers additional context to help them quickly and easily identify foods that can help them build a healthy eating pattern. This rule would also amend certain nutrient content claim regulations to align with current nutrition science and ensure consistency in labeling.
Status: Proposed rule published on May 9, 2025
Institutional Review Boards; Cooperative Research
This rule will replace current FDA requirements for cooperative research such that any institution located in the United States (U.S.) participating in multisite cooperative research will need to rely on approval by a single Institutional Review Board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. This rule will also establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.
Status: Proposed rule published on November 14, 2022
Medication Guide; Patient Medication Information
The rule will amend FDA medication guide regulations to require a new form of patient labeling, Patient Medication Information, for submission to and for approval by FDA for human prescription drug products and certain blood products used, dispensed, or administered on an outpatient basis. The rule will include requirements for the development and distribution of Patient Medication Information. The rule will require clear and concisely written prescription drug product information presented in a consistent and easily understood format and is intended to help patients use their prescription drug products safely and effectively.
Status: Proposed rule published on May 31, 2023
Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
The Food and Drug Administration (FDA) is amending its regulations to permit the use of salt substitutes in standardized foods in which salt (sodium chloride) is a required or optional ingredient. The rule would support industry efforts to reduce sodium content in standardized foods and improve dietary patterns by helping to reduce consumer sodium consumption.
Status: Proposed rule published on April 10, 2023
Amendment and Revocation of Organizational Information Regulations
The rule amends FDA's organizational information regulations in 21 CFR part 5 (subpart M, 5.1100 to 5.1110) to direct the public to up-to-date information on the Agency's organization (including its central and field offices) available on the Agency's website, as well as to information on relevant website and email addresses for FDA offices. The final rule also revokes certain regulations that are no longer necessary with this amendment. These changes provide the public with a uniform source of Agency organizational structure and contact information.
Status: Final rule published in the Federal Register on June 15, 2026
Revising the National Drug Code Format and Drug Label Barcode Requirements
The Food and Drug Administration (FDA) is amending its regulations governing the format of the National Drug Code (NDC). This action will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with three distinct segments. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, FDA is proposing to revise the drug product bar code label requirements to permit the use of linear or non-linear barcodes that meet certain standards.
Status: Final rule published in the Federal Register on March 5, 2026
Other actions in this stage
Rules open for, or headed toward, public comment.
Amendment of Regulations on Electronic Records and Electronic Signatures
This rule would amend FDA's regulations on electronic records and signatures in 21 CFR Part 11 to streamline and modernize requirements for ensuring the reliability, authenticity, and integrity of electronic records and signatures.
Agenda status: NPRM (planned)
Amendments to 21 CFR Parts 56 and 312; Expedited Investigational New Drug Application for Phase 1 Clinical Trial Reform
The Food and Drug Administration is proposing to amend 21 CFR 312 Subparts A, B, C, D and 21 CFR 56, for expedited Investigational New Drug (IND) reform. The proposed rule would make changes to general provisions related to the IND requirements, including process and IND content and format and sponsor responsibilities.
Agenda status: NPRM (planned)
Establishment Registration and Product Listing for Tobacco Products
FDA is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing for manufacturers of tobacco products. FDA needs complete and accurate establishment registration and product listing information to accomplish important statutory, regulatory, and public health objectives. Currently, only domestic manufacturers are required to register their establishments and list their tobacco products, creating significant gaps in agency information. This action, if finalized, would extend registration and listing requirements and FDA inspections to include foreign establishments and new categories of domestic establishments.
Status: Proposed rule published on June 29, 2026
Registration of Commercial Importers of Drugs; Good Importing Practice
This rulemaking meets the mandate of section 714 of the Food and Drug Administration Safety and Innovation Act and will establish registration and good importing practice requirements for commercial importers of drugs. Although manufacturers are subject to regulatory requirements to ensure such quality standards are met, there are few clear responsibilities for commercial importers of drugs to do the same. Cost estimates of the rule include reading and understanding the rule, registering as a commercial importer through the Food and Drug Administration's (FDA) electronic importer registration system, annual updating of registration, establishing a quality management system, conducting risk evaluations of drugs and suppliers, shipment verifications, investigations, corrective actions, and records maintenance. These incremental costs would be more than offset by cost savings to FDA and industry from facilitating the review of documentation that ensures compliance with our regulations prior to being allowed to enter the United States. The unquantified benefits of the rule include improvement in the safety of finished drugs allowed to enter the United States from the commercial drug importer's requirement to register with FDA and for increased due diligence required by the importer regarding the safety of the drugs. This rulemaking will also enhance FDA's ability to collect and analyze data to enable risk-informed decision-making while focusing on protecting the integrity of the global drug supply chain and ensuring safety, effectiveness, and quality of imported drugs.
Agenda status: NPRM (planned)
Transparency in Direct-to-Consumer Advertising
This rule will revise 21 CFR 202.1 to eliminate the option for prescription drug advertisements broadcast through media such as radio or television to fulfill the statutory brief summary requirement in section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by disclosing risk, contraindication, and other safety information in another source beyond the advertisement itself.
Agenda status: NPRM (planned)
Administrative Detention of Tobacco Products
FDA is proposing a regulation to establish requirements for the administrative detention of tobacco products. This rule, if finalized, would allow FDA to administratively detain tobacco products believed to be adulterated or misbranded that are encountered during inspections of manufacturers, vape shops, or other establishments that manufacture, process, pack, or hold tobacco products. The intent of administrative detention is to protect public health by preventing the distribution or use of tobacco products that are believed to be adulterated or misbranded until FDA has had time to consider the appropriate action to take and, where appropriate, to initiate legal action. This rule, if finalized, would be a critical enforcement tool to stop the distribution and sale of unauthorized tobacco products, such as illegal shipments of unauthorized e-cigarettes originating from overseas.
Agenda status: NPRM (planned)
Electronic Labeling for Medical Devices
This rule would clarify that the adequate directions for use requirement in section 502(f) of the Federal Food, Drug, and Cosmetic Act could be satisfied when labeling is provided solely by electronic means for certain types of devices in certain circumstances. FDA anticipates that this clarification would facilitate the communication of comprehensive and up-to-date information to users to provide reasonable assurance of the safety and effectiveness of such medical devices.
Agenda status: NPRM (planned)
Modernizing Regulations to Promote Electronic Submission and Reduce Paper Submission
This rule would amend FDA's regulations to promote electronic submissions and reduce paper submission, including by removing requirements for submission of multiple copies and replace them with the requirement for a single submission in electronic format. This action is being undertaken to revise regulations that required paper submission.
Agenda status: NPRM (planned)
Modification of Certain Terminology in Title 21
The Food and Drug Administration is issuing a rule to modify certain terminology in Title 21 of the Code of Federal Regulations to comply with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued on January 20, 2025. Specifically, this rule, if finalized, will remove the term gender wherever it appears and either replace it with the term sex, or delete reference to gender as applicable, along with other editorial changes to improve readability.
Status: Proposed rule published on May 6, 2026
Nutrient Content Claims for Added Sugars
The rule would update definitions, terminology, and provisions related to nutrient content claims and added sugars to be consistent with terms related to and updates to requirements for the Nutrition Facts label. The rule would, among other things, define a new "low added sugar" nutrient content claim that manufactures could voluntarily use to communicate information about the level of added sugars in food products.
Agenda status: NPRM (planned)
Pediatric Study Plan Requirements for New Drug and Biologics License Applications
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 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.
Agenda status: NPRM (planned)
Proactive Disclosure of Complete Response Letters
This rule will revise 21 CFR 312.130, 314.430, 601.51, and 814.9 to clarify and expand the discretion of the Commissioner of the Food and Drug Administration regarding the public release of Complete Response Letters (CRLs) and not approvable letters. This rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information.
Agenda status: NPRM (planned)
Substances Generally Recognized as Safe
This rule, if finalized, would amend FDA's regulations at 21 CFR parts 170 and 570 to require the submission of a generally recognized as safe (GRAS) notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use under section 201(s) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule would clarify that FDA maintain and update the public-facing GRAS notice inventory for all substances that are the subject of mandatory GRAS notice for the conditions of their intended use. The rule would also clarify the process under which FDA would determine that the use of a substance is not GRAS. This change would provide greater transparency about substances that are added to food, so that FDA can more efficiently determine if the use of a substance constitutes a food additive use that is subject to the premarket review and approval requirements under the FD&C Act.
Agenda status: NPRM (planned)
Other actions in this stage
On the agenda, but not expected to move within the next 12 months.
Investigational New Drug Application Annual Reporting
The rule will amend FDA's requirements concerning annual reports submitted by sponsors to investigational new drug applications (INDs) by replacing FDA's current annual reporting requirement with a new requirement for an FDA development safety update report (FDA DSUR). The annual FDA DSUR is intended to be consistent with the format and content of the DSUR supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and is more comprehensive and informative than the IND annual report currently required under FDA regulations.
Status: Proposed rule published on December 9, 2022
Protection of Human Subjects and Institutional Review Boards
This rule will harmonize, to the extent practicable and consistent with other statutory provisions, certain provisions of FDA's regulations on human subject protection and institutional review boards with the revised "Federal Policy for the Protection of Human Subjects" (the revised Common Rule (45 CFR part 46, subpart A)). The rule also finalizes minor amendments to related regulatory provisions.
Status: Proposed rule published on November 14, 2022
Requirements for Tobacco Product Manufacturing Practice
The rule would establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This rule would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products.
Status: Proposed rule published on August 29, 2023
Good Manufacturing Practice for Cosmetic Product Facilities
The rule, if finalized, would establish good manufacturing practices for cosmetic product facilities to help ensure the safety of cosmetic products.
Agenda status: NPRM (planned)
Other actions in this stage
Actions the agency reports as completed this cycle. The official agenda rule list files these separately from the active pipeline.
Medical Devices; Laboratory Developed Tests; Rescission
This rule will rescind the amendment to the Food and Drug Administration's regulations at 21 CFR 809.3(a) that added the words "including when the manufacturer of these products is a laboratory", reverting to the prior text of the regulation.
Agenda status: Final Rule Effective (planned)
Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-refusal and Post-hold Submissions
FDA is issuing this final rule to amend its prior notice regulations to add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number and add a requirement that prior notice and food facility registration information be submitted within a certain timeframe, after certain notices of refusal or hold have been issued ("post-refusal" and "post-hold" submission). The rule will also finalize certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.
Status: Final rule published in the Federal Register on September 25, 2025
Revocation of Food Standards for 11 Products Not Currently Sold
The Food and Drug Administration is revoking 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action removes obsolete rules to reduce unnecessary regulatory requirements. FDA published a direct final rule and a companion proposed rule on July 17, 2025, with the comment period ending on August 18, 2025. We stated that the effective date of the direct final rule would be September 22, 2025, unless we received a significant adverse comment during the comment period. We did not receive any significant adverse comments. Therefore, the direct final rule took effect on September 22, 2025.
Status: Final rule published in the Federal Register on September 26, 2025
Revocation of Methods of Analysis Regulation
The final rule revokes 2.19 (21 CFR 2.19), which states that it is FDA policy to use the methods of analysis of the AOAC International as published in the 1980 edition of Official Methods of Analysis of the Association of Analytical Chemists for FDA enforcement programs when the method of analysis is not prescribed in a regulation. Repeal of this regulation would eliminate an unnecessary policy.
Status: Final rule published in the Federal Register on February 19, 2026
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evalua
This final rule will revoke the regulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community. FDA is taking this action because the existing regulations have either been superseded by the 2017 amended Mutual Recognition Agreement (pharmaceutical annex) or are unnecessary, and do not reflect current Agency practice.
Status: Final rule published in the Federal Register on February 19, 2026
Other actions in this stage
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Create a free accountCompiled from the 2026 Regulatory Plan and Unified Agenda (reginfo.gov), cross-referenced against Federal Register publications. Regulation Roundup tracks all 89 FDA actions and refreshes as the agenda changes.