Biomedical Research

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

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)

Hearings to examine building a resilient health care future with biotechnology.

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)

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)

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec

Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance

HHS Request for Comment on the Update to the National Plan To Address Alzheimer's Disease

NASA Astronaut Chris Williams Closes Out Space Station Mission

A bill to amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants, and for other purposes.

AR-226-0183 - Study Plan: Perflurooctane Sulfonic Acid Induced HMG-CoA Reductase Inhibition in Pregnant Rats and Rat Pups

AR-226-0182 - Protocol for Study Nos. T-6295.23; ST-46: Exploratory In-Vitro Percutaneous Absorption Study of Theophylline, Salicylic Acid, Perfluorooctylsulfonate, and Ammonium Perfluorooctanoate in Skin Ethic Reconstituted Epidermis Model

AR-226-0180 - Protocol for Study No. T-7098.1: Pharmacokinetic Study of PFOS in Rats

AR-226-0173 - Pilot Teratology Study in Rats: T- 3551 Final Report, attached to memorandum to 3M (List of Section Attachments is first page of this file)