Regs.gov: Food and Drug Administration

FDA DMB Acknowledgment Letter to VIP Lighting NWA

FDA's Center for Devices and Radiological Health (CDRH) issued an acknowledgment letter to VIP Lighting NWA regarding submission FDA-2026-V-3710. The document serves as administrative confirmation of receipt of a filing, though the specific submission details are not publicly viewable in the available record. No regulatory obligations, deadlines, or penalties are stated in the acknowledgment.

Animal Generic Drug User Fee Act Reauthorization; Public Meeting and Comment Request

FDA announces a virtual public meeting on May 27, 2026 regarding the Animal Generic Drug User Fee Act (AGDUFA) reauthorization and requests public comments through December 1, 2027. The AGDUFA program, which funds FDA's review of generic animal drug submissions, expires September 30, 2028 without new legislation. FDA is soliciting input on program performance and suggestions for the next authorization.

FDA CTP Complaint Filed and Closed

FDA's Center for Tobacco Products (CTP) filed a complaint on April 16, 2026, which has since been closed. The document record indicates only that a complaint was filed and subsequently closed, with the full complaint content not available in the regulatory docket. No additional details regarding the nature of the complaint, parties involved, or any resulting enforcement actions are provided in the available metadata.

Qualitative Data Research Clearance Extension, OMB Control No. 0910-0891

The FDA published a notice under the Paperwork Reduction Act announcing an opportunity for public comment on extending OMB Control Number 0910-0891, the Generic Clearance for Qualitative Data to Support Social and Behavioral Research. The clearance covers submissions for qualitative data to support research related to food, dietary supplements, cosmetics, and animal food and feed. Comments must be submitted by June 16, 2026.

VarsIQ Media Ohio Variance Application - CDRH

FDA's Center for Devices and Radiological Health (CDRH) received a variance application from VarsIQ Media seeking relief from specific FDA regulatory requirements. The application was filed under docket FDA-2026-V-3708-0001 in Ohio. No supporting documents are currently available for review on the regulatory portal. This filing represents a request for FDA to exercise regulatory flexibility under applicable medical device regulations.

Arius Recordings LLC Variance Application

FDA's Center for Devices and Radiological Health (CDRH) received a variance application from Arius Recordings LLC. The application seeks relief or exemption from specific FDA regulatory requirements under 21 CFR. No documents are currently available for public viewing, and the application remains under agency review.

FDA Complaint FDA-2026-H-3613 Closed - No Documents Available

The FDA posted a complaint record (FDA-2026-H-3613) on April 17, 2025. The complaint was filed by the Center for Tobacco Products (CTP) and has been closed. No documents are available for public review or download. This is a procedural record indicating closure of an unspecified complaint matter.

FDA Center for Tobacco Products Files Complaint FDA-2026-H-3876

The FDA Center for Tobacco Products (CTP) filed a formal complaint (FDA-2026-H-3876-0001) on April 16, 2026. The complaint document is available as an attachment on Regulations.gov. No additional details about the specific allegations, parties involved, or requested relief are accessible in the available metadata.

Variance Approval to VarsIQ Media

The FDA Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to VarsIQ Media. Variances are exemptions or waivers from specific regulatory requirements under the Federal Food, Drug, and Cosmetic Act. This approval modifies the applicable regulatory requirements for VarsIQ Media, allowing deviation from certain standard CDRH requirements.

FDA Denies Citizen Petition FDA-2025-P-3263 from George W. Murgatroyd III

FDA CDER issued a final response letter denying citizen petition FDA-2025-P-3263 submitted by George W. Murgatroyd III. The petition was denied by the Center for Drug Evaluation and Research. No additional details are available as the document attachments contain personally identifiable information and are not publicly accessible.

UNLOXCYT Patent Extension Determination Comment Period

FDA has opened a public comment period regarding the patent extension determination for UNLOXCYT (a pharmaceutical drug product). Stakeholders may submit comments through the Regulations.gov portal. The comment form collects commenter identity, email address for confirmation, and optional attachments up to 20 files.

P210016 Safety Effectiveness Summary

FDA issued a Final Order for Premarket Approval P210016, including a Safety Effectiveness Summary for the Class III medical device. This order completes the FDA premarket approval review process, authorizing the device for market entry based on demonstrated safety and effectiveness data. The order applies to the device manufacturer holding PMA P210016.

P230025 Safety Effectiveness Data Summary

FDA issued a Final Order for Premarket Approval application P230025, summarizing the safety and effectiveness data reviewed for the medical device. The order documents FDA's determination that the device meets approval standards based on clinical and bench testing data submitted by the sponsor. This final order concludes the premarket review process for the device.

FDA Reclassifies Non-Invasive Bone Growth Stimulators to Class II

FDA issued a final order reclassifying non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II, subject to premarket notification (510(k)) and special controls. The devices, previously requiring premarket approval (PMA), are now subject to the less burdensome 510(k) pathway. The reclassification is effective May 18, 2026.

Stability Testing for Medicated Premixes Draft Guidance

FDA's Center for Veterinary Medicine (CVM) published draft guidance revising VICH GL8(R), updating stability testing requirements for medicated premixes used in veterinary medicine. The document is open for public comment through June 15. This guidance aligns U.S. requirements with international VICH harmonized standards for veterinary pharmaceutical products.

Stability Testing Medicated Premixes Draft Guidance

FDA has issued draft guidance on stability testing requirements for medicated premixes, opening a public comment period. The guidance applies to veterinary pharmaceutical manufacturers producing medicated feed premixes. Interested parties may submit comments through Regulations.gov. The docket number is FDA-2021-D-0613-0003.

FDA CTP Complaint Filed April 16, 2026

FDA's Center for Tobacco Products (CTP) filed a complaint on April 16, 2026, initiating formal enforcement proceedings against undisclosed parties for alleged violations of tobacco regulations under the Federal Food, Drug, and Cosmetic Act. The complaint, docketed as FDA-2026-H-3940-0001, is available on Regulations.gov with supporting documentation. This enforcement action may result in civil penalties, injunctive relief, or other remedies as determined through the administrative or judicial process.

UNLOXCYT Regulatory Review Period; Comment by Jun 15

UNLOXCYT Regulatory Review Period; Comment by Jun 15

Bernier 2009 FDA Regulatory Proceeding Citation

A 2009 FDA regulatory proceeding authored by Bernier has been cited and made available through the Regulations.gov docket system as part of a public filing (FDA-2026-P-3869-0069). The original document content is restricted due to copyright limitations. This reference represents an historical FDA regulatory proceeding that is being made accessible for regulatory record purposes.

Vessey 1986 Scientific Reference as FDA Background Material

A 1986 scientific reference authored by Vessey has been submitted as background material in connection with FDA submission FDA-2026-P-3869. This document provides supporting scientific context for the regulatory submission. The reference appears to be a peer-reviewed publication submitted to provide scientific support for safety or efficacy determinations in the associated FDA filing. No independent compliance obligations, deadlines, or enforcement actions are created by the submission of this reference document.

FDA Package Insert NDA 021323 Background Material

FDA has released background material supporting NDA 021323, which pertains to a package insert for a pharmaceutical product. The document was submitted through the FDA pre-market approval process and is part of the agency's review documentation. This background material is available for public access on Regulations.gov.

Scientific Literature Reference Rao 2017 FDA-2026-P-3869

A scientific literature reference (Rao 2017) has been submitted to FDA docket FDA-2026-P-3869. The document appears to be supporting scientific literature provided as part of comments or a submission to the FDA regulatory process. No regulatory requirements, deadlines, or penalties are established by this document submission.

Yang 2022 Scientific Literature Reference

A scientific literature reference authored by Yang (2022) was submitted to FDA docket FDA-2026-P-3869 as supporting documentation. The document was filed on April 3, 2025, and is accessible via regulations.gov. This appears to be part of a food additive petition or similar regulatory submission process requiring scientific literature support.

Scientific Reference Costenbader 2007, FDA-2026-P-3869

FDA has published a scientific reference document (Costenbader 2007) as part of docket FDA-2026-P-3869. The document was submitted as supporting scientific literature for a Pre-Market Notification submission. The actual content is restricted due to copyright and cannot be displayed.

Sanchez-Guerrero 1997 Scientific Literature Reference

FDA has received and filed a scientific literature reference (Sanchez-Guerrero 1997) in regulatory docket FDA-2026-P-3869. The document has been uploaded to the public docket and is accessible to interested parties. The content of the reference cannot be displayed due to copyright restrictions.

Scientific Literature Reference - Content Restricted

FDA received a submission on regulations.gov containing a scientific literature reference that is restricted due to copyright limitations. The specific content of the referenced literature is not accessible. The submission appears in FDA's docket system but the substantive regulatory material cannot be reviewed.

FDA Complaint FDA-2026-H-3943-0001

FDA received a complaint under docket FDA-2026-H-3943-0001 on April 15, 2025. The Center for Tobacco Products authored the complaint. The public comment period for this docket is now closed. No documents are available for viewing or download from the regulatory docket.

Citizen Petition to FDA by Kaylin Bower

A citizen petition was filed with the FDA's Center for Drug Evaluation and Research (CDER) by Kaylin Bower on April 15, 2026. The petition docket is FDA-2026-P-4104-0001. The full contents of the petition are redacted due to personally identifiable information protections, limiting visibility into the specific regulatory relief requested.

Scientific Literature Reference Copyright Restricted

FDA published a document on regulations.gov (FDA-2026-P-3869-0004) regarding scientific literature references. The submission contains copyright-restricted content and is not fully accessible to the public. The document appears to be a regulatory submission or comment filed with FDA.

Manhart 2013 Scientific Literature Submission FDA-2026-P-3869

FDA has received a docket submission to FDA-2026-P-3869 containing a citation to Manhart 2013 scientific literature. The full content of the submission is restricted due to copyright and is not publicly viewable in the docket.

Narula 2022 IBD Scientific Literature, FDA-2026-P-3869

Narula 2022 IBD Scientific Literature, FDA-2026-P-3869

Piovani 2019 Supplemental Tables Supporting FDA Petition

FDA received supplemental tables (Piovani 2019) as supporting material filed under docket FDA-2026-P-3869. The document contains scientific data tables submitted to support a petition or submission before the agency. Affected parties should monitor this docket for related FDA actions or correspondence.

Persson 1993 Background Material, FDA-2026-P-3869

FDA has posted background material submitted by Persson in docket FDA-2026-P-3869. The document, dated 1993, has been added to the public docket. The content is restricted due to copyright. No specific regulatory requirements or deadlines are stated in the available metadata.

Larsen 2008 FDA Document

This document (FDA-2026-P-3869-0117) appears in the FDA section of Regulations.gov. The full content is not accessible as it has been restricted due to copyright protections. No substantive regulatory requirements, deadlines, or obligations can be determined from the available metadata.

Persson 1993 Background Material Submission FDA Docket

FDA has received and placed in docket FDA-2026-P-3869 background material titled 'Persson 1993' for public access. The document contains copyrighted content that is restricted from public viewing. This appears to be historical scientific literature submitted as supporting material in an FDA regulatory proceeding. No new regulatory requirements, deadlines, or compliance obligations are established by this docket filing.

Hellwig 2016 Background Material - FDA Docket FDA-2026-P-3869

FDA received background material originally prepared in 2016 and filed in docket FDA-2026-P-3869. The document appears to be supporting documentation associated with an FDA petition. No new regulatory requirements or compliance obligations are established by this filing.

Konkle 2012 Background Material - FDA-2026-P-3869

FDA has received and posted background material (Konkle 2012) as part of docket FDA-2026-P-3869. The document content is restricted due to copyright and is not publicly accessible. The filing represents supporting documentation submitted to the FDA docket for regulatory review.

Klaus 1982 FDA Document

FDA received a document submission dated April 15, 1982, from Klaus. The document content is restricted due to copyright and is not publicly accessible through regulations.gov. The submission is catalogued under docket FDA-2026-P-3869-0005. Specific regulatory content cannot be determined from the available metadata.

Peragallo 2018 Supporting Material FDA-2026-P-3869

FDA received supporting materials for Citizen Petition FDA-2026-P-3869 submitted by Peragallo. The document consists of 2018 supporting material referenced in the petition but the content is restricted due to copyright. The petition and supporting documentation were filed in the public docket for regulatory review.

Ghajarzadeh 2022 Background Material for FDA Petition

FDA received background material from Ghajarzadeh dated 2022 as part of petition FDA-2026-P-3869. The submission consists of supporting documentation for a petition requesting FDA to take a specific regulatory action. The document was filed in the FDA regulations.gov docket system. No specific petition request, compliance obligations, or deadlines are stated in the available metadata.

Raglan 2019 Supporting Material

FDA received supporting material dated April 15, 2019, associated with submission FDA-2026-P-3869. The document content is restricted due to copyright. No specific regulatory requirements, deadlines, or penalties are stated in the visible portion of the document.

Chen 2017 Background Material, FDA-2026-P-3869, Apr 3

Chen 2017 Background Material, FDA-2026-P-3869, Apr 3

Acknowledgment Letter to Mom3nts Production

FDA's Center for Devices and Radiological Health (CDRH), Division of Manufacturers and Communication (DMB), issued an acknowledgment letter to Mom3nts Production. The letter confirms receipt of a submission filed under docket FDA-2025-V-3791. No documents are available for public viewing on Regulations.gov; the letter content is contained in an attachment.

FDA Center for Tobacco Products Complaint Submission

The FDA Center for Tobacco Products received a complaint document under docket FDA-2026-H-3868. The comment period has closed and no documents are available for public viewing. The nature and content of the complaint are not accessible through the regulatory filing system.

FDA Center for Tobacco Products Files Complaint - April 2026

The FDA Center for Tobacco Products (CTP) filed a complaint on April 14, 2026, initiating a formal enforcement action against tobacco product manufacturers. The complaint was submitted to regulations.gov under docket FDA-2026-H-3832. This filing represents FDA's regulatory enforcement mechanism for addressing violations of tobacco product standards under the Family Smoking Prevention and Tobacco Control Act.

Complaint Filed by Center for Tobacco Products

The FDA Center for Tobacco Products (CTP) filed a complaint with tracking number FDA-2026-H-3841. The complaint was submitted on April 14 and is now accessible via regulations.gov. Only a PDF attachment of the complaint is available for download; no summary documents are viewable on the regulatory portal.

B.E. Meyers & Co. Variance Application - CDRH

B.E. Meyers & Co., Inc. has submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH). The application requests permission to deviate from specific regulatory requirements applicable to the company's medical device operations. FDA has received and posted the application for public access via Regulations.gov under docket FDA-2025-V-4733-0001.

FDA Center for Tobacco Products Complaint Regarding Retailer Violation

The FDA Center for Tobacco Products (CTP) filed a complaint (FDA-2026-H-3866-0001) on April 14. The complaint relates to potential violations of federal tobacco product regulations, specifically concerning retailer compliance with sales and marketing requirements. The document represents a formal complaint filing within the FDA's regulatory enforcement process.

Variance Amendment - SRS Visual, CDRH

FDA's Center for Devices and Radiological Health (CDRH) issued a variance amendment related to SRS Visual. The variance was filed under docket FDA-2026-V-2145. The specific regulatory requirements being modified and the scope of the variance cannot be determined from available metadata as the full document content is not accessible.

Background Material for Docket FDA-2026-P-4022

FDA published background material under docket FDA-2026-P-4022 on April 14. The document contains supporting information related to a regulatory matter before the agency. No specific regulatory requirements, compliance deadlines, or penalties are stated in the available filing.