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ACHC Hospice Accreditation Reapproved by CMS

CMS has approved the reapplication of the Accreditation Commission for Health Care Inc. (ACHC) for continued status as a national accrediting organization for hospice programs under Medicare and Medicaid. The approval term runs from November 27, 2025 through November 27, 2031, a standard six-year renewal period. ACHC-accredited hospices will continue to receive deemed status for Medicare participation without requiring separate state agency certification.

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.

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.

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.

INJECTAFER Regulatory Review Period for Patent Extension

FDA has determined the regulatory review period for INJECTAFER (ferric carboxymaltose injection) for purposes of patent extension under 35 U.S.C. 156. The Agency published this notice as required by law following a patent extension application submitted to the USPTO. Any person with knowledge of incorrect dates may submit comments by June 2, 2026, or petition FDA regarding due diligence by September 30, 2026.

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.

FDA Survey Comment Form

The Food and Drug Administration (FDA) has opened a public comment period on a survey (Docket FDA-2026-N-2740-0001) via regulations.gov. The comment period remains open until June 2, 2026. This is a standard consultation seeking public input on an unspecified FDA survey topic.

VYLOY Patent Extension Application Comment Period

FDA opened a 60-day public comment period on a patent term extension application for VYLOY, a drug product. Commenters may submit feedback through regulations.gov regarding this application.

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.