Regs.gov: Food and Drug Administration

FDA Complaint Filed for Public Comment

The Food and Drug Administration (FDA) has opened a public comment period for a filed complaint related to its regulations. The complaint, authored by CTP, is available for review and download on regulations.gov. This action initiates a consultation period for interested parties to provide feedback.

FDA Complaint Document

The Food and Drug Administration (FDA) has posted a complaint document to the Federal Docket Management System. The document, authored by CTP, is available for review and download via the provided links.

Preeclampsia Risk and IVF Cycles Guidance

The Food and Drug Administration (FDA) has issued new guidance regarding the risk of preeclampsia associated with in vitro fertilization (IVF) cycles. This guidance aims to inform healthcare providers and patients about potential risks and management strategies.

FDA Complaint Filed and Closed for Comments

The Food and Drug Administration (FDA) has filed a complaint and opened it for public comment. The complaint is related to the Center for Tobacco Products (CTP) and has a filing date of March 27, 2026.

FDA Complaint Document Details

The Food and Drug Administration (FDA) has posted a complaint document related to its regulatory activities. The document is available for review on the regulations.gov portal, with a specific detail date of March 27, 2026. No further details on the nature of the complaint or its implications are provided in the initial posting.

FDA Complaint Document Posted

The Food and Drug Administration (FDA) has posted a complaint document related to its regulatory activities. This document is available for public review and comment, with a specific deadline for submissions.

DePaul University Variance Application

The FDA has posted a variance application submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform. No specific compliance actions or deadlines are indicated for other entities.

FDA CDRH Variance Approval Letter to Axion Laser

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Axion Laser. This document grants a specific variance, indicating an approved deviation from standard regulatory requirements for a particular product or process.

FDA Final Response Letter to Athyna Pharma LLC

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a final response letter to Athyna Pharma LLC. This document provides specific feedback and guidance related to the company's pharmaceutical development or regulatory submissions.

FDA Variance Request from Laina Callow - Comment Period Closed

The Food and Drug Administration (FDA) has closed the comment period for a variance request submitted by Laina Callow. The application, authored by CDRH, was available for public comment on regulations.gov.

FDA Acknowledges Letter to DePaul University

The Food and Drug Administration (FDA) has acknowledged receipt of a letter from DePaul University's Idea Realization Laboratory. This notice serves as an acknowledgment of the correspondence, with no further regulatory action or guidance provided at this time.

FDA Acknowledgement Letter to Premier Research International, LLC

The Food and Drug Administration (FDA) has issued an acknowledgement letter to Premier Research International, LLC. This notice confirms receipt of a submission, though no specific details about the submission's content or regulatory implications are provided.

FDA CDER Final Response Letter to Age Reversal Unity

The FDA's Center for Drug Evaluation and Research (CDER) has issued a final response letter to Age Reversal Unity regarding their submissions. The document is available through the Regs.gov portal.

FDA Acknowledgment Letter to Laina Callow

The Food and Drug Administration (FDA) has issued an acknowledgment letter to Laina Callow regarding a submission. The document is a redacted version of an acknowledgment letter from the FDA's Division of Management and Budget (DMB) to Laina Callow, authored by CDRH.

Citizen Petition Filed by Premier Research International LLC

Premier Research International LLC has filed a citizen petition with the Food and Drug Administration (FDA) regarding regulatory matters. The petition is available for public review and comment.

FDA Variance Application from Ingram Planetarium

The Food and Drug Administration (FDA) has posted a variance application from Ingram Planetarium. The application is available for review on Regulations.gov, with the author listed as CDRH.

FDA Acknowledgment Letter to Axion Laser

The Food and Drug Administration (FDA) has issued an acknowledgment letter from its Division of Management and Budget (DMB) to Axion Laser. This notice confirms receipt of a submission, though no specific details about the submission's content or purpose are provided in the available information.

FDA Decision on Tradipitant New Drug Application Refusal

The Food and Drug Administration (FDA) has issued a final decision regarding the new drug application for Tradipitant. The agency has decided to refuse to approve the application, based on a proposal to do so. The specific details of the decision are confidential business information, but a redacted version is available.

FDA Variance Approval Letter to Dapper Rave, LLC

The Food and Drug Administration (FDA) has issued a variance approval letter to Dapper Rave, LLC, through its Center for Devices and Radiological Health (CDRH). This document signifies an approval for a specific variance requested by the company.

FDA Variance Approval Letter

The Food and Drug Administration (FDA) has issued a variance approval letter to Laina Callow. The letter, originating from the Center for Devices and Radiological Health (CDRH), indicates a specific approval related to a medical device or process. A redacted version is available for public review.

FDA Variance Amendment from DePaul University Idea Realization Laboratory

The Food and Drug Administration (FDA) has posted a variance amendment submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform, with an associated attachment from the Center for Devices and Radiological Health (CDRH).

FDA Complaint Document Details

The Food and Drug Administration (FDA) has posted details regarding a complaint document, with the information made available on March 26, 2026. The document is related to the Center for Tobacco Products (CTP) and is available for download.

FDA Complaint Document - Closed for Comments

The Food and Drug Administration (FDA) has opened a public comment period for a new complaint document, identified by docket number FDA-2026-H-2944. The comment period is scheduled to close on March 26th.

FDA Completeness Assessment Correspondence

The Food and Drug Administration (FDA) has posted Completeness Assessment Correspondence related to drug applications. This notice indicates that documentation is available for review via the provided URL, though no specific documents are directly viewable or downloadable from the initial posting.

FDA Variance Approval Letter to DePaul University

The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to DePaul University's Idea Realization Laboratory. This document signifies approval for a specific variance related to medical device development or testing.

FDA Variance Application from Axion Laser

The Food and Drug Administration (FDA) has posted a variance application from Axion Laser. This document is available for review on the FDA's regulations.gov portal.

FDA Acknowledgment Letter to Ingram Planetarium

The Food and Drug Administration (FDA) has issued an acknowledgment letter to Ingram Planetarium regarding a submission. The letter, dated March 26, 2026, confirms receipt of documentation from the Center for Devices and Radiological Health (CDRH). No specific details about the submission's content or regulatory implications are provided.

FDA Complaint Filed

The FDA has posted a complaint filed on March 25, 2026. The complaint was authored by CTP and is now closed for comments. No documents are available for viewing or download.

Letter from USPTO to FDA CDER

The U.S. Patent and Trademark Office (USPTO) has sent a letter to the FDA's Center for Drug Evaluation and Research (CDER). The document is available for review on Regulations.gov, though no content is directly viewable within the portal.

FDA Complaint Filed and Closed for Comments

The FDA has filed a complaint related to tobacco products, with the comment period now closed. The specific details of the complaint and the affected parties are not available in the provided document.

Letter from U.S. Patent Office to FDA CDER

The FDA has posted a letter received from the U.S. Patent and Trademark Office addressed to the FDA's Center for Drug Evaluation and Research (CDER). The document is available for review on Regulations.gov.

USPTO Letter to FDA CDER

The U.S. Patent and Trademark Office (USPTO) has sent a letter to the FDA's Center for Drug Evaluation and Research (CDER). The document is available on Regs.gov, but no content or specific details of the letter's subject matter are provided.

USPTO Letter to FDA CDER

The U.S. Patent and Trademark Office (USPTO) sent a letter to the FDA's Center for Drug Evaluation and Research (CDER). The document was posted on March 25, 2025, via Regs.gov. No content is available for viewing or download, only metadata about the letter.

Patent Office Letter to FDA CDER

The FDA has posted a letter from the U.S. Patent and Trademark Office addressed to the FDA's Center for Drug Evaluation and Research (CDER). The document is available for review on Regulations.gov.

USPTO Letter to FDA CDER

The U.S. Patent and Trademark Office (USPTO) has sent a letter to the FDA's Center for Drug Evaluation and Research (CDER). The document is a notification, and no specific regulatory action or compliance requirement is detailed within the available information.

FDA CDER Letter from U.S. Patent and Trademark Office

The FDA has posted a letter from the U.S. Patent and Trademark Office to its Center for Drug Evaluation and Research (CDER). The document is dated March 25, 2026, and is available for review on Regs.gov.

FDA CDER Receives Letter from U.S. Patent Office

The FDA's Center for Drug Evaluation and Research (CDER) has received a letter from the U.S. Patent and Trademark Office. The document is available for review on Regulations.gov, though no specific content is provided in the listing.

USPTO Letter to FDA CDER

The U.S. Patent and Trademark Office (USPTO) sent a letter to the FDA's Center for Drug Evaluation and Research (CDER). The document was posted on March 25, 2024, via Regulations.gov. No specific details or content of the letter are available.

FDA Complaint Document

The FDA has posted a complaint document related to its Center for Tobacco Products (CTP). The document is available for review on Regulations.gov, though no specific details of the complaint are provided in the notice.

FDA Complaint Document

The FDA has posted a complaint document, FDA-2026-H-2883-0001, on March 25, 2026. The document is available via a link to regulations.gov, though no content is directly viewable or downloadable from the initial posting.

FDA Variance Renewal Request from Shine On Floyd Band

The Food and Drug Administration (FDA) has received a variance renewal request from Shine On Floyd Band. The document is available for review on regulations.gov, though no specific details or content are provided within the listing itself.

FDA Complaint Document

The FDA has posted a complaint document related to FDA-2026-H-2608. The document is available for review, though no specific details about its content are provided in the initial posting. This notice serves to inform the public and relevant parties of the complaint's availability.

FDA Completeness Assessment Correspondence

The FDA has posted Completeness Assessment Correspondence related to drug applications. This notice provides information from the Center for Drug Evaluation and Research (CDER) regarding the completeness of submitted applications.

Letter from U.S. Patent Office to FDA CDER

The FDA's Center for Drug Evaluation and Research (CDER) has posted a letter received from the U.S. Patent and Trademark Office. The document is dated March 25, 2026, and is available for review on Regulations.gov.

FDA Complaint Filed

The Food and Drug Administration (FDA) has filed a complaint related to tobacco products. The comment period for this filing has closed. No further details on the nature of the complaint or specific parties involved are available in the provided information.

FDA Complaint Posted

The FDA has posted a complaint on March 25, 2026, which was closed for comments. The complaint document is available for download from the agency's regulations.gov portal.

FDA Complaint Posted

The FDA has posted a complaint related to its regulations, with the comment period closing on March 25, 2026. The document is available for review on Regs.gov.

FDA Complaint Document

The FDA has posted a complaint document related to its regulatory activities. The document is available for download and further information can be accessed via the provided link. This notice serves to inform the public about the availability of this complaint.

FDA Complaint Document

The Food and Drug Administration (FDA) has posted a complaint document related to its activities. This document is now closed for public comments. The FDA has provided a link to download the complaint document.

FDA Delays Effective Date for Spirulina Extract Color Additive

The FDA is delaying the effective date of its final order regarding the expanded use of spirulina extract as a color additive in human foods. This delay is due to timely objections and a request for a hearing filed by Obelisk Tech Systems Inc. The agency will publish a future document to announce a new effective date or other administrative action.