Healthcare & Public Health

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Health Benefits Election Form

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Standards and Certification

2026-11012

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry

2026 Ebola Entry Screening, Monitoring, & Traveler Feedback 2026-11013

Use of the Cyclosporiasis National Hypothesis Generating Questionnaire (CNHGQ) During Investigations of Foodborne Disease Clusters and Outbreaks 2026-11011

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Penn Highlands Healthcare (Community Comment)

Partial Response

Acknowledgment Letter from FDA DMB to Hyman, Phelps & McNamara, P.C.

Citizen Petition from Hyman, Phelps & McNamara, P.C.

Attachment 1 - Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations

Acknowledgement Letter from FDA DMB to Lachman Consultant Services, Inc.

Suitability Petition from Lachman Consultant Services, Inc.

Data Request (DR001): Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Purchased/Referred Care Delivery Area Redesignation: Kewa Pueblo

Advancing Violence Epidemiology in Real-Time (AVERT) 2026-10513

Hearings to examine the reality of Medicaid.