- The Spring 2025 Unified Agenda
- The Make America Healthy Again Commission Releases Its Strategy Report
- CDER & CBER New Rare Disease Evidence Principles (RDEP)
- Launch of Green List for GLP-1 Ingredients
The Spring 2025 Unified Agenda Officially Released
Last week, the Trump administration's Office of Information and Regulatory Affairs (OIRA) officially released the Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions. Notably, the Agenda includes several significant FDA rulemaking plans, such as:
- Rescission of the Laboratory Developed Tests Rule
- Final Rule Expected: September 2025
- Registration of Commercial Importers of Drugs; Good Importing Practice
- Proposed Rule Expected: September 2025
- Requiring mandatory GRAS notifications
- Proposed Rule Expected: October 2025
- For more detail, see our analysis of FDA’s statutory authority for mandatory GRAS notifications.
- Prohibiting the use of formaldehyde and formaldehyde-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products marketed in the U.S
- Proposed Rule Expected: December 2025
- Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
- Proposed Rule Expected: February 2026
- Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products
- Proposed Rule Expected: March 2026
- Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings, Wound Dressings Formulated as a Gel, Cream, or Ointment, and Liquid Wound Washes
- Proposed Rule issued November 30, 2023
- Final Rule Expected: May 2026
- Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
- Proposed Rule issued March 20, 2024
- Final Rule Expected: May 2026
- Biologics Regulation Modernization
- Proposed Rule Expected: October 2026
- Advancing cosmetic regulations required by the Modernization of Cosmetic Regulation Act of 2022 (MoCRA). The MoCRA related rules include:
- Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
- Proposed Rule issued December 27, 2024
- Final Rule Expected: March 2026
- Disclosure of Fragrance Allergens in Cosmetic Labeling
- Proposed Rule Expected: May 2026
- Good Manufacturing Practice (GMP) for Cosmetic Product Facilities
- Proposed Rule Expected: To Be Determined
- Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
We will continue to track these regulatory actions and report the implications for stakeholders.
The Make America Healthy Again Commission Releases Its Strategy Report
On September 9, the Department of Health and Human Services (HHS) announced the release of the Make America Healthy Again Commission's Make Our Children Healthy Again Strategy, which outlines a range of initiatives to "end childhood chronic disease." FDA-related actions highlighted in the strategy include:
- Continuing efforts to limit or prohibit the use of petroleum-based food dyes, while accelerating the review and approval of natural color additives
- Advancing the development and implementation of an enhanced, evidence-based process for the post-market assessment of chemicals in food
- Partnering with USDA and HHS to establish a definition for "ultra-processed food"
- Exploring options for providing greater flexibility in the use of "no artificial color" and other labeling claims and
- Issuing a rule making Generally Recognized as Safe (GRAS) notifications mandatory
FDA has already begun to implement, or announced its intent to implement, some of these initiatives. We will continue to monitor these and any other actions taken pursuant to the strategy. For additional insights, check out this episode of FDA Watch, where our partner and co-chair of the Food and Drug Law Group, Claudia Lewis, discusses the Agency's efforts to regulate ultra-processed foods.
CDER & CBER New Rare Disease Evidence Principles (RDEP)
On September 3, FDA introduced the Rare Disease Evidence Principles (RDEP) process developed and implemented by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The process intends to "provide greater speed and predictability in the review" of treatments for certain rare diseases. Under RDEP, drugs may be approved based on a single well-controlled study that may be a single-arm trial, plus robust data that provides strong confirmatory evidence of the drug's treatment effect (e.g., data from non-clinical models or case reports). Eligibility for RDEP is limited to therapies that specifically correct a known genetic defect causing a rapidly progressing, disabling, or fatal disease, affecting a very small population (typically under 1,000 patients), with no adequate alternative treatments that alter the disease course. FDA's full summary of the RDEP process can be found here.
Launch of Green List for GLP-1 Ingredients
Recently, FDA announced that it has established a "green list" import alert (Import Alert 66-80) to facilitate the Agency's efforts to prevent "potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market." GLP-1 APIs on the green list—originating from FDA-inspected or evaluated facilities that meet the Agency's standards—will be permitted entry into the U.S. Shipments of APIs from other sources will face detention without physical examination (DWPE).
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions about how the contents of this article may impact you or your business′s interactions with the FDA, please contact the authors today.