Pharmaceutical Policy

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)

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Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers; Revised Draft Guidance for Industry

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

Medication Affordability and Patent Integrity Act

Medication Affordability and Patent Integrity Act

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

Citizen Petition from End Kratom Addiction

Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.

Expedited Access to Biosimilars Act

Expedited Access to Biosimilars Act

Patients Deserve Price Tags Act

Patients Deserve Price Tags Act

SAFE Drugs Act of 2026