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 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FDA confirms STRATTERA not withdrawn for safety

FDA confirms STRATTERA not withdrawn for safety

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.

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 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.

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 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.

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.

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.