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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 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.

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to declare insulin detemir a medically necessary drug in shortage, provide guidance on demonstrating biosimilarity for withdrawn drugs, and permit 503B outsourcing facilities to compound the drug.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.

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.

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 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.

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.

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.

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.

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.