Biomedical Research

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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance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(QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability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Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance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Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance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)

AR-226-0172 - Displacement of a Fluorescently Labeled Fatty Acid Analogue from Fatty Acid Carrier Proteins by Wyeth-14,643, Ammonium Perfluorooctanoate, Potassium Perfluorooctane Sulfonate & Other Known Peroxisome Proliferators: Abstract-Soc. of Tox. Annual Meeting

AR-226-0171 - Effect of Acute FC Administration on Catalase and acylCoA Oxidase Expression

AR-226-0170 - Effects of Selected Perfluoro-Compounds on Mitochondrial Beta-Oxidation

AR-226-0169 - Summary of the Effects of PFC's on Mitochondrial Bioenergetics in vitro

AR-226-0167 - The Effect of Perfluorinated Arylalkylsulfonamides on Bioenergetics of Rat Liver Mitochondria

AR-226-0166 - Effect of N-Alkyl Perfluorooctylsulfonamides on Mitochondrial Bioenergetics in vitro (Executive Summary and Attachment A: "Biochemical and Molecular Mechanistic Studies of N- Alkyl Perfluorosulfonamides" only)

AR-226-0164 - Perfluorosulfonamide Metabolism in Rat vs. Human Hepatocytes