Regs.gov: Food and Drug Administration

Variance Application, Christ The King Lutheran Church, FDA, North Carolina

Christ The King Lutheran Church in North Carolina submitted a variance application to the FDA Center for Devices and Radiological Health (CDRH) under docket FDA-2026-V-3505. The specific regulatory requirements or medical device standards at issue are not disclosed in the available metadata. No documents are currently available for public review on Regulations.gov.

FDA CDRH Approves Variance for Church

FDA CDRH Approves Variance for Church

Center for Tobacco Products Complaint, Apr 13, 2026

FDA Center for Tobacco Products (CTP) filed a complaint on April 13, 2026. The document is classified as closed in the Regulations.gov system (Docket FDA-2026-H-3804). The full complaint text is not available for public viewing on the regulatory portal. This appears to be a formal complaint related to tobacco product regulation.

BILTRICIDE Not Withdrawn for Safety or Effectiveness

FDA has determined under 21 CFR 314.161 that BILTRICIDE (praziquantel) oral tablet, 600 mg, was not withdrawn from sale for reasons of safety or effectiveness. The drug product, which was discontinued by Bayer Healthcare Pharmaceuticals in February 2024 and moved to the Orange Book's Discontinued Drug Product List, retains its eligibility for ANDA approvals. Novitium Pharma LLC submitted a citizen petition requesting this determination, which FDA granted based on review of Agency records.

FDA DMB Acknowledgment Letter to Hyman Phelps McNamara

FDA Division of Manufacturing and Quality (DMB) within CDER sent an acknowledgment letter to Hyman, Phelps & McNamara, P.C. in response to submission FDA-2026-P-4018. The acknowledgment indicates receipt of the submission without substantive review or determination at this stage. No regulatory obligations, compliance deadlines, or enforcement actions are imposed by this document.

Suitability Petition to FDA

Hyman, Phelps & McNamara, P.C. filed a Suitability Petition with the FDA under docket FDA-2026-P-4020-0001. The petition appears to request FDA approval for a drug product change under applicable administrative procedures. The filing was submitted to CDER for review.

FDA Suitability Petition, Comment Period Open

FDA Suitability Petition, Comment Period Open

GSK Withdraws Wellcovorin (Leucovorin Calcium) NDA Approval

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GlaxoSmithKline's written request. GSK notified FDA that the drug products are no longer marketed. Existing inventory may continue to be dispensed until depleted or reaching expiration dates.

CDRH Acknowledgment Letter to Shane Parker - FDA-2025-V-5013

FDA CDRH issued an acknowledgment letter to Shane Parker in response to submission FDA-2025-V-5013. The acknowledgment letter confirms receipt of the submission but the actual document content is not publicly available due to personally identifiable information protections.

Environmental Impact Statement Background Material

FDA published background material supporting an Environmental Impact Statement (EIS) for a pre-market submission (FDA-2026-P-3840). The document provides supporting context for environmental review of the regulated product or facility. Interested parties may review the materials on Regulations.gov.

FDA DMB Acknowledgement Letter to Emprise Pharma LLC

FDA Division of Manufacturing Standards (DMB) issued an acknowledgement letter to Emprise Pharma LLC on behalf of Shandong New Time Pharmaceutical Co., Ltd on April 10. The letter confirms receipt or filing status of a submission related to pharmaceutical manufacturing. This is standard administrative correspondence and does not constitute approval, denial, or any substantive regulatory determination.

Color Additive Certification PRA Extension, Comments Due June 9, 2026

FDA is soliciting public comments on extending an existing information collection under the Paperwork Reduction Act concerning color additive certification. Comments must be submitted by June 9, 2026. This PRA notice follows standard federal procedures for renewing agency data collection authorizations.

ANDA vs 505(b)(2) Applications

FDA issued guidance clarifying distinctions between Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications for drug approvals. The document helps pharmaceutical manufacturers determine the appropriate regulatory pathway based on their drug product characteristics and supporting data requirements.

Food Additive Petitions Comments Due Jun 9

FDA is soliciting public comments on information collection requirements for food and color additive petitions, including labeling, master file submissions, and electronic submissions using Form FDA 3503. The 60-day comment period closes June 9, 2026. Comments will be posted to Docket No. FDA-2026-N-2743 on regulations.gov.

FDA Requests Comments on Medical Device Premarket Approval Information Collection Under PRA

FDA Premarket Approval, Comment Period Ends Jun 9

Variance Approval Letter for Shane Parker

FDA CDRH issued a variance approval letter to Shane Parker under docket FDA-2025-V-5013. The variance grants an exception or deviation from standard CDRH regulatory requirements for a specific medical device matter. The approval letter (redacted version available) represents a binding regulatory determination by FDA.

Suitability Petition - Emprise Pharma on Behalf of Shandong New Time

Emprise Pharma LLC filed a suitability petition with FDA on behalf of Shandong New Time Pharmaceutical Co., Ltd requesting agency determination on proposed changes to an approved drug product. The petition has been assigned docket number FDA-2026-P-3840-0001 and is under review by CDER.

Letter from USPTO to FDA CDER Regarding Patent Matters

The USPTO sent correspondence to FDA's Center for Drug Evaluation and Research on April 9 regarding patent-related matters. The document is filed under docket FDA-2026-E-3821-0001 and is available only as an attachment PDF on regulations.gov.

Milestone Pharma Patent Term Extension Application

FDA received a patent term extension application from Clark & Elbing LLP on behalf of Milestone Pharmaceuticals, Inc. The application seeks to extend patent protection for a drug product regulated by CDER. Patent term restoration may compensate for regulatory review time under applicable law.

Milestone Pharmaceuticals Patent Term Extension Application

Clark & Elbing, LLP filed a patent term extension application on behalf of Milestone Pharmaceuticals, Inc. with the FDA's Center for Drug Evaluation and Research (CDER). The application seeks to extend patent protection for a pharmaceutical product to compensate for regulatory review time. Patent term extensions under 35 U.S.C. 156 can extend patent terms by up to 5 years.

USPTO Letter to FDA CDER on Patent Matters

The USPTO sent a letter to FDA's Center for Drug Evaluation and Research on April 9, 2026, regarding patent-related matters. The correspondence appears to address inter-agency coordination on pharmaceutical patent issues. No documents are available for public viewing in the regulatory docket.

USPTO Letter to FDA CDER Regarding Patent Matters

USPTO sent a letter to FDA CDER regarding patent-related matters. The document contains limited content available for public review, with the full letter available only as an attachment. This represents routine inter-agency communication on intellectual property matters affecting pharmaceutical regulation.

Letter to FDA CDER Regarding Patent Matter

USPTO transmitted correspondence to FDA CDER regarding a patent-related matter. The letter is filed under docket FDA-2026-E-3811-0001 and is accessible as a PDF attachment. Specific content details are not visible in the available document metadata.

USPTO Letter to FDA CDER Regarding Patent Procedures

The USPTO transmitted correspondence to FDA's Center for Drug Evaluation and Research regarding patent-related procedures. The letter was filed in the regulatory docket on April 9, 2026. This inter-agency communication addresses administrative patent matters between the two federal agencies.

USPTO Letter to FDA CDER on Patent Matters, Apr 8

USPTO sent an inter-agency letter to FDA CDER regarding patent-related matters. The communication appears in a FDA regulatory docket and addresses coordination between the two agencies on intellectual property issues. No specific regulatory requirements or compliance obligations are detailed in the available documentation.

FDA Requirement for Patent Information to Clark & Elbing

FDA Requirement for Patent Information to Clark & Elbing

Projected Reality variance application, FDA, California, Apr 8

Projected Reality variance application, FDA, California, Apr 8

Amended Citizen Petition - Insulin Detemir Drug Shortage and Biosimilarity Guidance

Alliance to Protect Insulin Choice submitted amendments to its citizen petition requesting FDA to declare insulin detemir a medically necessary drug in shortage, provide guidance on demonstrating biosimilarity for withdrawn drugs, and permit 503B outsourcing facilities to compound the drug. The petition addresses access concerns following detemir's withdrawal from the U.S. market.

FDA Issues Priority Review Voucher for LOARGYS (pegzilarginase-nbln)

The FDA announced issuance of a priority review voucher to Immedica Pharma AB for LOARGYS (pegzilarginase-nbln), approved February 23, 2026. The drug treats hyperargininemia in adults and pediatric patients 2 years and older with Arginase 1 Deficiency. The voucher was awarded under section 529 of the FD&C Act for rare pediatric disease products meeting specified criteria.

CDER Interim Response Letter to Age Reversal Unity

FDA CDER issued an interim response letter to Age Reversal Unity regarding submission FDA-2025-P-4985, a Pre-Request for Designation (Pre-IND or similar drug development query). The letter provides preliminary feedback or requests additional information but does not constitute a final regulatory determination. The company must address agency concerns before a final response is issued.

FDA Center for Tobacco Products Complaint Document

The FDA Center for Tobacco Products (CTP) filed a formal complaint document on April 7, 2026, via Regulations.gov docket FDA-2026-H-3303. The complaint, authored by CTP staff, initiates an enforcement proceeding against one or more regulated entities for alleged violations of federal tobacco product regulations. The specific allegations and parties involved are contained in the attachment but are not accessible for review in this summary.

FDA Administrative Practices and Procedures Information Collection Comment Request

The FDA published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection under the Paperwork Reduction Act of 1995. The collection covers general FDA administrative practices and procedures, including requests for formal hearings. Comments must be submitted by June 8, 2026 via regulations.gov or mail.

E2B(R3) Data Standards for Postmarketing Individual Case Safety Reports

FDA announces updated data standard requirements for postmarketing individual case safety reports (ICSRs) for human drug products, biological products, and drug- or biologic-led combination products. Starting October 1, 2026, all ICSR submissions to the FDA Adverse Event Monitoring System (AEMS) database via the Electronic Submissions Gateway Next Generation must use ICH E2B(R3) data standards, replacing the current E2B(R2) standard. The public comment period closes October 1, 2025.

FDA CTP Complaint - No Documents Available

The FDA Center for Tobacco Products (CTP) filed a formal complaint (FDA-2026-H-3091-0001) on regulations.gov. The docket indicates that a complaint has been initiated, though the underlying documents are not available for viewing. This represents a formal enforcement action by FDA's tobacco regulatory division against one or more regulated parties.

Variance Approval Letter to Primo Entertainment Inc

FDA's Center for Devices and Radiological Health (CDRH) approved a variance request from Primo Entertainment Inc, granting the company relief from specific regulatory requirements under federal standards for electronic products or radiation-emitting devices. The variance pertains to the company's entertainment products that fall under FDA's radiation safety jurisdiction.

Variance Application - Primo Entertainment Inc

FDA received a variance application from Primo Entertainment Inc (New York) on March 13, 2026. The application was submitted to the Center for Devices and Radiological Health (CDRH) for review. No associated documents are currently available for public viewing on the regulatory docket.

FDA confirms STRATTERA not withdrawn for safety

FDA confirms STRATTERA not withdrawn for safety

FDA Suitability Petition Amendment - Hyman Phelps & McNamara

Law firm Hyman, Phelps & McNamara, P.C. filed an amendment to a suitability petition with FDA's Center for Drug Evaluation and Research (CDER). The petition seeks a regulatory determination regarding drug product suitability under the Federal Food, Drug, and Cosmetic Act. FDA will review the amended petition and issue a determination on whether the requested drug product meets suitability requirements for approval pathways.

FDA Complaint - Tracking mno-s34f-ax16

FDA received a complaint filed on April 7, 2025, tracked under identifier mno-s34f-ax16 (docket FDA-2026-H-3442-0001). The complaint was submitted by CTP (Center for Tobacco Products) and is accessible via regulations.gov. No documents are currently available for viewing or download from the docket.

FDA CTP Complaint - Closed for Comments

The FDA Center for Tobacco Products filed a complaint (Docket FDA-2026-H-3161-0001) that was closed for comments on April 3, 2026. The complaint document was submitted through regulations.gov and is now archived. No documents are available for public viewing in this docket.

FDA Petition Attachment - Content Restricted

FDA received a petition (FDA-2026-P-3664) with restricted attachment content. The document appears to be a regulatory filing submitted to the agency. Specific substance and scope cannot be determined due to copyright restrictions on the attachment.

VYLOY Patent Extension Notice Comment

FDA is accepting public comments on a patent term extension notice for VYLOY (cisplatin), a chemotherapy drug. Comments are being submitted through Regulations.gov docket FDA-2025-E-0863. The notice relates to potential patent term extension eligibility under the Drug Price Competition and Patent Term Restoration Act.

VYLOY Regulatory Review Period Patent Extension Comment Form

FDA opened a public comment period on the regulatory review period patent extension for VYLOY (vonoprazan), a potassium-competitive acid blocker approved for gastric acid-related conditions. Comments are being accepted through regulations.gov docket FDA-2025-E-0845. Stakeholders may submit comments on behalf of themselves, organizations, or anonymously.

VYLOY Patent Extension Comment Period

FDA has opened a public comment period on a patent term extension application for VYLOY (citizens乏 details unspecified). Comments on FDA-2025-E-0866-0006 must be submitted by June 2, 2025. This consultation allows interested parties to provide input on the patent extension determination.

ZIIHERA Patent Extension Comment Form

FDA has opened a public comment period on Regulations.gov for a patent extension related to ZIIHERA. The comment form is accessible for submission of feedback by interested parties including pharmaceutical companies, manufacturers, and individuals. The docket number is FDA-2025-E-0372-0005.

Patent Extension Comment Period

FDA has opened a 60-day public comment period for a patent extension matter under docket FDA-2025-E-3074-0006. The agency is seeking stakeholder input on the EMRELIS patent extension proposal. Interested parties may submit comments through Regulations.gov.

Background Material Supporting Proposed Regulatory Action

The FDA published background material supporting docket FDA-2026-P-3665. This document provides supplementary information related to a proposed regulatory action in the pharmaceutical or medical product space. The docket is open for public review and potential comment submission.

EMRELIS Patent Extension Comment Form

FDA has opened a public comment period for EMRELIS patent extension matter via regulations.gov docket FDA-2025-E-3073. The 60-day comment window allows interested parties to submit feedback on the patent term extension application. Commenters may submit as individuals, organizations, or anonymously with attachments up to 10MB.

FDA Acknowledgement of Submission from Hyman Phelps McNamara

FDA CDER issued an acknowledgement letter to Hyman, Phelps & McNamara, P.C. regarding a submission under docket FDA-2026-P-3664-0002. The acknowledgement confirms receipt of the submission but no substantive regulatory action is detailed in the available metadata.

ENFLONSIA Patent Extension Consultation

The FDA is seeking public comments on an ENFLONSIA patent extension application (Docket FDA-2025-E-3626-0006). Comments must be submitted by June 2, 2025 via Regulations.gov. This consultation follows standard FDA procedures for pharmaceutical patent-related matters.