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August 18, 2020

Table of Pharmacogenomic Biomarkers in Drug Labeling

Abacavir Infectious Diseases HLA-B Boxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions Abemaciclib (1) Oncology ESR(Hormone Receptor) Indications and Usage, Adverse Reactions, Clinical Studies Abemaciclib […]
August 18, 2020

Drug Trials Snapshots: EVRYSDI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 18, 2020

Drug Trials Snapshots: VILTEPSO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 18, 2020

Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes FDA’s compliance policy related to the retention of reserve samples of the […]
August 17, 2020

CDER Leadership Bios

Eric Stone, M.B.A.Director, Office of Management Eric Stone is Director of CDER’s Office of Management. He also serves as the CDER Executive Officer and CDER’s Associate […]
August 17, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020

For Immediate Release: August 17, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
August 17, 2020

Drug Trials Snapshots: BLENREP

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
August 17, 2020

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

For Immediate Release: August 17, 2020 The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in […]
August 17, 2020

Drug Trials Snapshots: LAMPIT

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
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