Regs.gov: Food and Drug Administration

FDA Survey Comment Form

The Food and Drug Administration (FDA) has opened a public comment period on a survey (Docket FDA-2026-N-2740-0001) via regulations.gov. The comment period remains open until June 2, 2026. This is a standard consultation seeking public input on an unspecified FDA survey topic.

VYLOY Patent Extension Application Comment Period

FDA opened a 60-day public comment period on a patent term extension application for VYLOY, a drug product. Commenters may submit feedback through regulations.gov regarding this application.

VYLOY Patent Extension Comment Period Notice

The FDA has opened a 60-day public comment period for a patent extension application related to the drug VYLOY (zolbetuximab). Pharmaceutical companies and other interested parties may submit comments on the patent term restoration matter. The comment period provides an opportunity for stakeholders to voice concerns or support regarding the extension.

ENCELTO Regulatory Review Period Determination for Patent Extension

The FDA has determined the regulatory review period for ENCELTO, a human biological product, and published this notice as required by law for patent extension purposes. Any person may submit comments on the accuracy of the published dates by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

INJECTAFER Regulatory Review Period for Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) for purposes of patent extension under 35 U.S.C. 156. The Agency published this notice as required by law following a patent extension application submitted to the USPTO. Any person with knowledge of incorrect dates may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

Determination of Regulatory Review Period for EMRELIS Patent Extension

FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this determination as required by law. The notice allows interested parties to comment on the accuracy of dates and to petition FDA regarding due diligence during the review period.

Medical Device Variance Renewal - Redhouse Productions

FDA CDRH approved a variance renewal for Redhouse Productions (FDA-2023-V-2753-0004). The variance allows deviation from standard medical device manufacturing requirements under specific conditions. The renewal maintains previously granted flexibilities for the regulated entity.

Complaint Regarding Potential Regulatory Violation

FDA posted a complaint under docket FDA-2026-H-3081-0001 on April 3, 2026. The complaint, authored by CTP (Center for Tobacco Products), relates to a potential regulatory violation. No documents are currently available for review on regulations.gov.

ENFLONSIA Regulatory Review Period Determination

FDA has determined the regulatory review period for ENFLONSIA, a human biological product, as required by 35 U.S.C. 156 for patent extension purposes. The notice invites public comment on whether the published dates are incorrect and allows interested parties to petition FDA regarding the applicant's due diligence during the review period.

VYLOY Patent Extension Regulatory Review Period Determination

The FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required under 35 U.S.C. 156. The notice invites comments on whether any published dates are incorrect by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026.

Customer Service Satisfaction Surveys - PRA Comment Request

The FDA is seeking public comments on proposed customer service satisfaction surveys under the Paperwork Reduction Act of 1995. The 60-day comment period closes June 2, 2026. This is a routine information collection request; no new burdens are proposed as it involves existing customer service survey collections.

FDA determines regulatory review period for VYLOY patent extension

The Food and Drug Administration has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required by 35 U.S.C. 156 for patent extension purposes. The determination is part of a batch of regulatory review period notices (dockets FDA-2025-E-0845 through FDA-2025-E-0872). Comments on date accuracy are due June 2, 2026, and petitions regarding due diligence may be filed by September 30, 2026.

VYLOY Patent Extension Regulatory Review Period Determination

The Food and Drug Administration has determined the regulatory review period for VYLOY, a human biological product, for purposes of patent extension under federal law. The notice invites public comments on the accuracy of published dates by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026. This determination affects patent extension calculations for the branded drug manufacturer.

Variance Application from BF Light Shows, Michigan

FDA CDRH received a variance application from BF Light Shows, a Michigan-based entity, seeking regulatory relief or alternative compliance pathway under FDA electronic product radiation control requirements. The application was filed under docket FDA-2026-V-2878.

FDA complaint, CTP author, posted 3rd Apr

FDA complaint, CTP author, posted 3rd Apr

VYLOY Regulatory Review Period Determination for Patent Extension

The FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The notice solicits public comments on the accuracy of the published dates and allows interested parties to petition FDA regarding whether the applicant acted with due diligence during the review period. Comments on date accuracy are due June 2, 2026, and due diligence petitions are due September 30, 2026.

Determination of Regulatory Review Period for VYLOY Patent Extension

FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The Agency is publishing this notice to allow interested parties to comment on the determination or petition for redetermination regarding due diligence. Multiple patent extension applications (FDA-2025-E-0845 through FDA-2025-E-0872) are included in this notice.

VYLOY Patent Extension Regulatory Review Period Determination

FDA has determined the regulatory review period for VYLOY, a human biological product, and is publishing this determination as required by law for patent term extension applications. Interested parties may submit comments on the dates or petition FDA regarding due diligence. Comment deadline is June 2, 2026, and petition deadline is September 30, 2026.

Tobacco Product Citizen Complaint

FDA Center for Tobacco Products received and closed a citizen complaint (FDA-2026-H-3165) for comments. The complaint is now in closed status with no documents available for public review. No regulatory action or compliance requirements identified.

FDA Complaint Filed with Center for Tobacco Products

FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-3164-0001. The complaint has been closed for comments, indicating the administrative filing process is complete. No documents are available for public review at this time.

Determination of Regulatory Review Period for ZIIHERA

FDA has determined the regulatory review period for ZIIHERA, a human biological product, as required by law for patent extension calculations. The notice invites comments on the determination and sets deadlines for challenges. Interested parties may submit comments by June 2, 2026, and petitions regarding due diligence by September 30, 2026.

EMRELIS Patent Extension Regulatory Review Period Determination

FDA has determined the regulatory review period for EMRELIS, a human biological product, for purposes of patent extension under federal law. The notice opens a public comment period until June 2, 2026, and allows interested parties to petition FDA regarding the applicant's due diligence by September 30, 2026. This determination affects the calculation of any patent term extension.

FDA Complaint Regarding Tobacco Product Regulations

The FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-2955-0001. The complaint has been closed for further comments. The specific allegations and parties involved are not publicly viewable as the underlying documents are not available for download on regulations.gov.

FDA reviews patent extension for cancer drug VYLOY

FDA reviews patent extension for cancer drug VYLOY

ZIIHERA Regulatory Review Period Determination for Patent Extension

FDA has determined the regulatory review period for ZIIHERA, a human biological product, as required by law for patent extension applications. The notice publishes these dates and provides timelines for public comments and petitions. Comments on date accuracy are due June 2, 2026, and petitions regarding due diligence are due September 30, 2026.

Vyloy Patent Extension Regulatory Review Period Determination

FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required by law. The determination is relevant to patent extension applications submitted to USPTO. Interested parties may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

EMRELIS Regulatory Review Period Determination for Patent Extension

FDA has determined the regulatory review period for EMRELIS, a human biological product, and published this notice as required by law for patent extension purposes under 35 U.S.C. 156. The determination affects the patent term extension calculation for the product's New Drug Application submitted to USPTO.

CTP Complaint Against Tobacco Product Company

The FDA Center for Tobacco Products filed and closed a complaint (FDA-2026-H-3163-0001) on April 3, 2026. The specific allegations, respondent identity, and resolution details are contained in the attached complaint document. This represents routine enforcement activity under FDA's tobacco product authority.

ENFLONSIA Patent Extension Regulatory Review Period Determination

FDA published a notice determining the regulatory review period for ENFLONSIA, a human biological product, for purposes of patent extension under 35 U.S.C. 156. The notice allows interested parties to comment on the accuracy of published dates by June 2, 2026, and to petition FDA regarding the applicant's due diligence by September 30, 2026. Docket No. FDA-2025-E-3626.

FDA patent extension review, Injectafer, ends Sep 30

FDA patent extension review, Injectafer, ends Sep 30

FDA refuses TRADIPITANT Capsules approval, hearing denied

FDA refuses TRADIPITANT Capsules approval, hearing denied

Center for Tobacco Products Enforcement Complaint

The FDA Center for Tobacco Products filed an enforcement complaint on March 31, 2026, under docket FDA-2026-H-3142. The complaint addresses alleged violations of tobacco product regulations. The respondent must respond to the specific allegations contained in the filed complaint.

Tobacco Product Enforcement Complaint

The FDA Center for Tobacco Products (CTP) filed a complaint on March 31, 2026, docketed as FDA-2026-H-3146. The document initiates an enforcement action against a regulated entity regarding tobacco product compliance. The specific allegations and parties involved are contained in the PDF attachment available through Regulations.gov.

FDA Complaint Document Closed for Comments

The Food and Drug Administration (FDA) has closed a complaint document for public comments. The document, authored by CTP, is available for download via a link on regulations.gov. No specific details about the complaint's content or its regulatory impact are provided.

FDA Final Response

The Food and Drug Administration (FDA) has posted a final response related to docket FDA-2022-P-2644-0046. The document, authored by CDRH, is available via the provided URL and download link.

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, filed on March 27, 2026, is available for review and submission of feedback.

FDA Acknowledgement Letter to Steranco Healthcare Pvt. Ltd.

The Food and Drug Administration (FDA) has issued an acknowledgement letter to Steranco Healthcare Pvt. Ltd. The letter confirms receipt of documentation related to a submission. No specific details regarding the nature of the submission or any required actions are provided in the available information.

Mifepristone Clinical Indications Systematic Review Document

The Food and Drug Administration has issued a systematic review document regarding the clinical indications for mifepristone. This document outlines the FDA's review process and findings related to the drug's approved uses.

PGT-A using human in vivo - Part 1 & 2

The Food and Drug Administration (FDA) has made available two attachments related to the first PGT-A (Preimplantation Genetic Testing for Aneuploidy) performed using human in vivo. These documents, authored by CDER, provide supplementary information on this specific application of PGT-A.

FDA Document on Uterine Lavage and Live Births

The Food and Drug Administration (FDA) has issued a document concerning uterine lavage and its relation to live births. This notice provides information on the topic, likely for public awareness or to inform stakeholders in the healthcare and pharmaceutical sectors.

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, filed on March 27, 2026, is available for review and submission of feedback through the Regs.gov portal.

Appco Pharma LLC Suitability Petition

The Food and Drug Administration (FDA) has received a suitability petition from Appco Pharma LLC. The petition is related to drug manufacturing and regulatory filings.

FDA Complaint Document

The Food and Drug Administration (FDA) has posted a complaint document related to its regulatory activities. The document, authored by CTP, is available for review on Regulations.gov. No specific compliance actions or deadlines are indicated.

FDA Acknowledgement Letter to Charlene Peters

The Food and Drug Administration (FDA) has issued an acknowledgement letter to Charlene Peters regarding a submission. The letter, authored by CDER, confirms receipt of the document. No specific details about the submission's content or regulatory implications are provided.

FDA Complaint Document

The Food and Drug Administration (FDA) has posted a complaint document related to its regulatory activities. The document, authored by the Center for Tobacco Products (CTP), is available for review and download via the regulations.gov portal.

FDA Supporting Material for Proposed Rule

The Food and Drug Administration (FDA) has posted supporting material for a proposed rule on March 27, 2026. This material is associated with docket number FDA-2026-P-3242. The posting provides additional context and data related to the proposed regulatory action.

Citizen Petition from Charlene Peters

The Food and Drug Administration (FDA) has received a citizen petition from Charlene Peters. The petition is currently available for review, with a redacted version provided for public access.

FDA Complaint Document Posted for Comments

The Food and Drug Administration (FDA) has posted a complaint document for public comment, with the comment period closing on March 27, 2026. The document is related to a complaint filed by CTP.

FDA Background Material for Docket FDA-2026-P-3242

The Food and Drug Administration (FDA) has posted background material related to docket FDA-2026-P-3242. This material is available for public review and does not impose new regulatory requirements.

FDA Complaint Docket FDA-2026-H-3040

The Food and Drug Administration (FDA) has opened a new complaint docket, FDA-2026-H-3040, related to a complaint filed by CTP. No documents are currently available for viewing or download within this docket.