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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.

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 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.

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 reviews patent extension for cancer drug VYLOY

FDA reviews patent extension for cancer drug VYLOY

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.

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.

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.

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.