Regs.gov: Food and Drug Administration

FDA Variance Application from Life to the Full, LLC

The FDA has posted a variance application from Life to the Full, LLC. The application details are available via a link on the Regs.gov portal. No documents are currently available for direct viewing or download.

FDA Complaint Document

The FDA has posted a complaint document related to its regulatory activities. The document is available for review on the Regs.gov platform. No specific details about the nature of the complaint or the parties involved are provided in the metadata.

FDA Acknowledges Letter from 3 Foot World

The FDA has acknowledged receipt of a letter from 3 Foot World regarding a matter associated with docket FDA-2026-V-1589. The agency has provided a link to the acknowledgment letter, which was authored by CDRH.

FDA Variance Approval Letter

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter. The document is restricted due to Personally Identifiable Information and a redacted version is available for download.

FDA Variance Approval Letter to Laser Wizardry

The FDA has issued a variance approval letter to Laser Wizardry regarding a medical device. This document is part of the regulatory process for medical device manufacturers seeking specific approvals or variances from standard requirements.

FDA Acknowledgment Letter to Kyle Cummings

The FDA has posted an acknowledgment letter sent to Kyle Cummings regarding a submission. The letter is from the FDA's Division of Management and Budget (DMB) and was authored by CDRH. A redacted version is available for download.

FDA Variance Approval Letter for Vault Entertainment Inc.

The Food and Drug Administration (FDA) has issued a variance approval letter to Vault Entertainment Inc. This document grants a specific variance related to regulatory requirements. The FDA's Center for Devices and Radiological Health (CDRH) authored the letter.

FDA Variance Application from Mykyta Sukhenko

The FDA has posted a variance application submitted by Mykyta Sukhenko. The application is restricted due to personally identifiable information, but a redacted version is available for review. This notice serves to inform the public of the application's existence.

FDA Variance Approval Letter to Mykyta Sukhenko

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Mykyta Sukhenko. The document is restricted due to personally identifiable information, but a redacted version is available.

FDA Complaint Document

The FDA has posted a complaint document related to its regulatory activities. No content is available for viewing or download, but an attachment labeled 'Complaint' is provided by the CTP author.

FDA Variance Renewal from Lapis Lasers & Lighting FX

The FDA has posted a variance renewal request from Lapis Lasers & Lighting FX, LLC. The document is available for review and download via the Regs.gov portal. No specific details on the variance itself are provided in the metadata.

FDA Acknowledgment Letter to Whisky A Go Go

The Food and Drug Administration (FDA) has issued an acknowledgment letter to Whisky A Go Go. The letter, originating from the Center for Devices and Radiological Health (CDRH), confirms receipt of correspondence but provides no further details on its content or implications.

FDA Complaint Posted for Public Comment

The FDA has posted a complaint for public comment, with the comment period closing on March 19, 2026. The document is available on Regulations.gov, though no content is directly viewable, only an attachment labeled 'Complaint' from the author CTP.

FDA Complaint Filed

The FDA has filed a complaint regarding a matter related to its regulatory oversight. The document indicates that comments were closed on March 19, 2026. No specific details about the complaint's nature or the parties involved are available in the provided metadata.

FDA Variance Application - Furew Floral Event and Landscaping

The Food and Drug Administration (FDA) has received a variance application from Furew Floral Event and Landscaping. The application, submitted by CDRH, is available for review on Regs.gov.

FDA Letter to U.S. Patent and Trademark Office

The Food and Drug Administration (FDA) has posted a letter addressed to the U.S. Patent and Trademark Office. The document is available on Regulations.gov and was authored by the Center for Drug Evaluation and Research (CDER).

FDA Letter to U.S. Patent Office

The Food and Drug Administration (FDA) has issued a letter to the U.S. Patent and Trademark Office. The letter is authored by CDER and was posted on March 19, 2026. No documents are available for viewing or download.

FDA Letter to Patent Office

The Food and Drug Administration (FDA) has issued a letter to the U.S. Patent and Trademark Office (USPTO). This communication is related to the Center for Drug Evaluation and Research (CDER) and is part of the FDA's ongoing regulatory processes. The comment period for this notice has closed.

FDA Variance Application from JSMJ Group LLC

The FDA has received a variance application from JSMJ Group LLC. The application pertains to medical device regulations. No documents are currently available for viewing or download.

FDA Variance Application from Kenyon Productions, LLC Closed

The Food and Drug Administration (FDA) has closed a variance application submitted by Kenyon Productions, LLC. The specific details of the variance and the reasons for its closure are not provided in the available document.

FDA Completeness Assessment Correspondence

The FDA has issued a completeness assessment correspondence to Hyman, Phelps & McNamara, P.C. regarding a submission. The document is a standard communication within the drug approval process and does not contain new regulatory requirements or guidance.

FDA Variance Application from Jennifer Rishel

The FDA has posted a variance application submitted by Jennifer Rishel. The application, filed by CDRH, is available in redacted format on regulations.gov. No specific details on the nature of the variance or its implications are provided in the posting.

FDA Variance Approval Letter to DJ Ken-E. Ken

The Food and Drug Administration (FDA) has posted a Variance Approval Letter related to DJ Ken-E. Ken. The document was issued by the Center for Devices and Radiological Health (CDRH). No other details or documents are available for viewing.

FDA Variance Amendment from Furew Floral Event

The FDA has posted a variance amendment related to the Furew Floral Event and Landscaping. This document, authored by CDRH, is available for review on Regulations.gov. No specific compliance actions or deadlines are detailed in the provided information.

FDA CDRH Variance Approval Letter to Furew Floral

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Furew Floral Event and Landscaping. This document signifies an approval for a specific variance requested by the company.

FDA Variance Amendment from Leo Weeks Photographers

The FDA has posted a variance amendment submitted by Leo Weeks Photographers. The document is available for review on Regulations.gov, though no specific details or full text are provided directly in the listing.

FDA CDRH Variance Approval Letter to Smack Shack

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Smack Shack. This document grants a specific variance, the details of which are not publicly available in the provided text.

FDA Variance Amendment from Whisky A Go Go

The Food and Drug Administration (FDA) has posted a variance amendment related to "Whisky A Go Go." The document is available for review on regulations.gov, though no specific details or downloadable content are provided directly in the listing.

FDA Guidance on Physicochemical Characterization of Topical Drug Products

The FDA has issued final guidance for industry on the physicochemical and structural characterization of topical drug products submitted in Abbreviated New Drug Applications (ANDAs). This guidance, which finalizes a draft from October 2022, provides recommendations to support bioequivalence demonstrations for generic topical products.

FDA PRIA Reference SBA Size Standards Update

The FDA has posted an update regarding the Presolicitation Information and Analysis (PRIA) Reference, specifically concerning Small Business Administration (SBA) size standards. This notice updates the reference document used by the agency for certain regulatory processes.

FDA Economic Analysis of CDRH Submission Requirements

The FDA has published an economic analysis concerning the submission requirements for the Center for Devices and Radiological Health (CDRH). This analysis provides insights into the economic impact of these requirements on medical device manufacturers.

FDA Medical Device User Fee Rates for FY 2024

The Food and Drug Administration (FDA) has posted the Medical Device User Fee rates for Fiscal Year 2024. This notice provides the updated fee schedule for medical device manufacturers.

FDA Document on Biochemical Changes in Red Blood Cells

The FDA has posted a document concerning biochemical changes in red blood cells. The document is available for review on Regs.gov, though specific details are restricted due to copyright.

FDA Radiology Devices Classification Regulatory Analysis

The FDA has published a regulatory analysis concerning the classification of radiology devices. This notice provides an overview of the agency's approach to classifying these medical devices, offering clarity to manufacturers and stakeholders.

FDA Guidance on EpCAM-Positive Cell Reduction by Filters

The FDA has issued guidance concerning the reduction of EpCAM-positive cells by filters. This document provides information relevant to drug manufacturers and medical device makers.

FDA PRIA Reference Data

The FDA has published reference data related to the Prescription Drug User Fee Act (PRIA) for May 2024. This notice includes national employment data relevant to PRIA submissions. It serves as an informational update for regulated entities.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2575-0001. The document was made available on March 17, 2026, and is authored by CTP.

FDA Complaint Document

The FDA has posted a complaint document to the Regs.gov portal. The document, authored by CTP, is available for review and download. No specific details regarding the nature of the complaint or its implications are provided in the metadata.

Harmony Foods Multivitamin Gummies - FDA Docket

The FDA has opened Docket FDA-2025-S-0024 concerning Harmony Foods Multivitamin Gummies. An attachment from Harmony Foods LLC provides details on their Meijer Wellness Women's Multivitamin Gummies.

FDA - Swanson Health Products Menopause Support

The FDA has posted a document related to Swanson Health Products' Menopause Support supplement. The document, identified as FDA-2025-S-0024-1968, is available for review on the Regs.gov platform. No specific regulatory action or compliance requirement is detailed in the provided information.

FDA Closes Comment Period for Blueroot Health Nutrient Submission

The FDA has closed the public comment period for a nutrient submission from Blueroot Health concerning their B6 + B Complex product. The submission was related to energy metabolism support. No further action is required from the public at this time.

FDA Complaint Consultation

The FDA has posted a complaint for public comment, with the comment period closing on March 17, 2026. This action allows stakeholders to provide input on the complaint's content.

FDA Document on GreenBio Nutrients Joint Health Capsules

The FDA has posted a document related to GreenBio Nutrients Inc.'s ILEXPOWER and JointAlive Capsules. The document is available for review on the Regs.gov platform. No specific regulatory action or compliance requirement is detailed in the provided information.

FDA Acknowledgment Letter to Lusonix Group

The FDA has posted an acknowledgment letter sent to Lusonix Group regarding a submission. The letter, authored by CDRH, confirms receipt of materials but provides no further details on the nature of the submission or any regulatory actions.

Luxsonix Group Variance Approval Letter

The FDA has issued a variance approval letter to Luxsonix Group. This notice pertains to a specific variance granted by the Center for Devices and Radiological Health (CDRH).

FDA Consultation on i-Health Inc. Culturelle Gummies

The FDA has opened a comment period regarding i-Health Inc.'s Culturelle Women's Probiotic + Multivitamin Gummies. This consultation seeks public input on the product, with specific details available via the provided link.

FDA: L-Theanine Powder Supports Relaxation Claim

The FDA has received a submission regarding L-Theanine Powder, specifically from Threshold Enterprises (Source Naturals), for its product that claims to support relaxation and ease everyday stress. This notice indicates a submission for a dietary supplement claim.

FDA - Vitanica BreastBlend Claim Review

The FDA has received a submission regarding Vitanica's BreastBlend product, which claims to support healthy breast tissue. This notice indicates the FDA is aware of the product and its claims, but no specific regulatory action or enforcement is detailed in the provided information.

FDA - Better Being Co. Solaray StressMag Product Information

The FDA has posted information regarding Better Being Co.'s Solaray StressMag product, which claims to support mood and relaxation. This filing appears to be a notification or informational submission related to a specific product. No new regulations or enforcement actions are detailed.

FDA - Harmony Foods LLC. Meijer Fiber Gummies Submission

Harmony Foods LLC. has submitted information regarding their Meijer Fiber Gummies 72ct product to the Food and Drug Administration (FDA). This submission is part of the agency's regulatory process for food products.