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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.

ACHC Hospice Accreditation Program Reapproved by CMS

CMS has approved the reapplication of Accreditation Commission for Health Care Inc. (ACHC) as a national accrediting organization for hospice programs under Section 1865(a)(1)(A) of the Social Security Act. The approval term runs from November 27, 2025 through November 27, 2031. This allows ACHC-accredited hospices to receive deemed status for Medicare and Medicaid participation in lieu of state survey agency reviews.

ACHC Critical Access Hospital accreditation approved by CMS

CMS announces continued approval of the Accreditation Commission for Health Care Inc. (ACHC) as a national accrediting organization for critical access hospitals (CAHs) participating in Medicare or Medicaid programs. The approval extends for six years from December 27, 2025, through December 27, 2031, maintaining the deemed status pathway for CAHs.

CDC DELTA Cooperative Agreement Public Comment

CDC has opened a 52-day public comment period for the DELTA Cooperative Agreement (Docket CDC-2026-0364-0001) on Regulations.gov. The comment form allows individuals and organizations to submit feedback on the proposed cooperative agreement. Comments may be submitted as individuals, organizations, or anonymously.

FDA patent extension review, Injectafer, ends Sep 30

FDA patent extension review, Injectafer, ends Sep 30

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.

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.

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.

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.

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.