Effective January 20, 2025, The President issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries.
The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any rulemaking or similar regulatory activity until the new administration has had an opportunity to review what the previous administration proposed or promulgated. In this case, the order:
- Precludes federal agencies from proposing or issuing a rule until a department or agency head appointed or designated by the current administration reviews and approves the rule.
- Requires agencies to withdraw rules that have been sent to the Federal Register but not published so they can be reviewed and approved.
- Directs agencies to “consider postponing” for 60 days the effective date for rules that have been published or issued in the Federal Register but have not taken effect so they can be reviewed regarding questions of fact, law, and policy that the rules may raise.
While these regulatory actions are subject to review it does not mean they will be discarded or rescinded. However, these rules will be reviewed by the new administration. After which, they will move forward unchanged, withdrawn, or subject to additional rulemaking activities.
EAS Consulting Group will closely monitor these and other FDA updates throughout 2025 and beyond, communicating expectations and analyses to our clients as available.
A few of the affected actions:
- The FDA has finalized their guidance document “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA | FDA” which explains the process under which a type II API DMF will undergo an early assessment (prior assessment), 6 months prior to an ANDA or PAS submission referencing the DMF. Recommendations for DMF holders are also included.
- The FDA has issued a Proposed Administrative Order OTC 000036 (Amending OTC M012) to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as a nasal decongestant active ingredient.
- The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU).
- The FDA has announced their proposed rule to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products in the Federal Register Vol. 89, No. 248 published 27 December 2024.
In the meantime, a thorough review of your regulatory compliance systems may be warranted so that you will be able to quickly understand and pivot to the FDA expectations. Reach out to your regulatory partners at EAS Consulting Group for help determining regulatory compliance.
The agency announced on 15 January 2025, that Authorization for the use of Red No. 3 in food and ingested drugs will be revoked. This action comes in response to a 2022 color additive petition requesting the agency to review their approval decision taking the Delaney Clause into account. Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until 15 January 2027 or 18 January 2028, respectively, to reformulate their products. Further details can be reviewed in the Federal Register Vol 90, No. 10 notice Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs.
Given the significant challenge faced by both industry and regulators in Determining Recommended Acceptable Intake Limits for N-nitrosamine Impurities in Pharmaceuticals, the FDA and international regulators developed a methodology that uses the chemical structure of a nitrosamine impurity to recommend AI limits. The Carcinogenic Potency Categorization Approach (CPCA) assigns a predicted potency category reflecting carcinogenic risk. Follow the link to read the FDA’s discussion and details about this approach.
Now that we have entered the first year post cosmetic registration and listing requirements, it’s a good time to review your records and make sure you are prepared for your update / renewal process. For facility registrations, an update should be submitted within 60 days of any changes to the information required for the registration (see section C.1 of the Guidance for Industry). The biennial renewal submission must align with your initial facility registration (renewal must be submitted in the same month your initial registration was submitted, 2 years after first registering). Do note, this is the only registration renewal process that falls outside the Oct-Dec renewal period. Your records will dictate when to submit your biennial renewal. For a cosmetic product listing, updates should be submitted annually. Important to remember with a cosmetic product listing, the following fields cannot be updated in a listing file: Product name; Ingredients (including fragrance, color, and flavor); Product categories and Responsible person. If changes are needed to any of these noted fields the original cosmetic listing must be discontinued and a new product listing must be submitted. The required cosmetic product listing annual renewal has an abbreviated process for any cosmetic listing that has had no change to the required information. If a product has been discontinued, that would be considered a required annual update, and the listing should be submitted to reflect this status.
Highlighted Guidance Documents
Pulse Oximeters – Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
Document issued on: March 4, 2013
This document supersedes Non-invasive Pulse Oximeter General Guidance Document, September 7, 1992. FDA has developed this guidance document to assist industry in preparing premarket notifications (510(k)s) for pulse oximeters. These devices are intended for non-invasive measurement of the arterial blood oxygen saturation and pulse rate.
Bioanalytical Method Validation for Biomarkers
This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.
Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)
This guidance describes the Food and Drug Administration’s approach regarding manufacturers’ compliance with FDA’s performance standards for laser products.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
This guidance describes FDA’s interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act. This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
This guidance describes FDA’s interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act. This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act
This guidance is intended to assist interested parties in the implementation of section 506J. This guidance serves as the baseline for information about notifications under section 506J (hereafter referred to as “506J notifications”) during or in advance of any PHE. If FDA determines it is appropriate, we may issue individual, PHE-specific updates as appendices to this guidance or individual, PHE-specific guidance documents, among other potential options. Such decisions will be made on a case-by-case basis and will be determined by the specific situation and informational need.
This guidance includes a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act (hereafter referred to as the “506J Device List”). Additionally, FDA has clarified that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency
Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers
This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. This guidance is not for current implementation, pending the Office of Management and Budget’s (OMB’s) decision on the collection of information.
The following are DRAFT Guidance Documents available for comment.
DRAFT Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
Submit Comments by 02/28/2025
DRAFT Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency
Submit Comments by 03/07/2025
DRAFT Considerations for Complying with 21 CFR 211.110
Submit Comments by 04/07/2025
DRAFT Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
Submit Comments by 04/07/2025
DRAFT Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
Submit Comments by 04/07/2025
All Guidance Documents can be searched on the FDA’s website.
Federal Register
FR Vol. 90, No. 4, Tuesday, January 7, 2025 Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request
FR Vol. 90, No. 4, Tuesday January 7, 2025 Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability
FR Vol. 90, No. 11, January 17, 2025 Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments
Meetings
Joint US FDA – Health Canada ICH Public Meeting 2025
Date: February 11, 2025
Time: 11:00 a.m. – 3:00 p.m. ET
Navigating Controlled Correspondences to Support Generic Drug Development
Date: February 27, 2025
Time: 1:00 p.m. – 3:30 p.m. ET
Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions
Date: March 13, 2025
Time: 1:00 p.m. – 3:00 p.m. ET
2025 PDG-FDA Town Hall- Manufacturer Exemption, DSCSA Implementation Progress Toward End of Manufacturer Exemption
Date: Wed, Mar 26, 2025
Time: 1:00 — 3:00 PM EDT
Generic Drugs Forum (GDF) 2025
Dates: April 9 – 10, 2025
Day1: Wed, Apr 09 8:30 a.m. – 05:00 p.m. ET
Day2: Thu, Apr 10 8:30 a.m. – 05:00 p.m. ET
Location:
Bethesda North Marriott
Hotel & Conference Center
5701 Marinelli Road
Rockville, MD 20852
United States
2025 PDG-FDA Town Hall- Wholesale Distributor Exemption, DSCSA Implementation Progress Toward End of Wholesale Distributor Exemption
Date: Wed, Jun 25, 2025
Time: 1:00 — 3:00 PM EDT
2025 PDG-FDA Town Hall- Dispenser Exemption, DSCSA Implementation Progress Toward End of Dispenser Exemption
Date: Wed, Sep 24, 2025
Time: 1:00 — 3:00 PM EDT
FDA Websites of Interest
- FDA Solicits Public Comments on Use of Cannabis-Derived Products in Veterinary Medicine
- Advancing Real-World Evidence Program
- Medical Device Reporting, Complaints, and Corrections & Removals Reporting: Laboratory Developed Tests FAQs
- July – September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Posted in Drug and Device Corner, Drugs, Medical Devices.