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October 8, 2020

DDT COA #000125: Endurance Shuttle Walking Test (ESWT)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Pulmonary, Allergy, and Critical Care (DPACC) DDT COA NumberDDT COA #000125 Instrument NameEndurance Shuttle […]
October 8, 2020

Biomarker Qualification Program

SPOTLIGHT Events & Announcements Web content is updated for consistency with 21st Century Cures Act! Get Started with your submission: Resources for Biomarker Requestors MISSION The […]
October 8, 2020

Animal Model Qualification (AMQP) Program

Qualification of an animal model[1] through FDA’s Animal Model Qualification Program (AMQP) is voluntary (i.e., not required for product approval or licensure under the Animal Rule)[2].  […]
October 8, 2020

Animal Model Qualification: Frequently Asked Questions (FAQs)

Do animal models have to be qualified?  No; submitting an animal model for qualification is voluntary. Is the use of a qualified animal model required for […]
October 8, 2020

Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions

Below are CDER’s COA Qualification Program’s frequently asked questions (FAQs). We also recommend reviewing the general COA FAQ web page. General CDER COA Qualification Program Information: […]
October 7, 2020

A Culture of Responsibility: Laboratory Safety at the FDA

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Segaran Pillai, Ph.D., Designated Agency Safety and Health Official and the Director of the […]
October 7, 2020

Conceptos básicos de los Biosimilares para los pacientes

Materiales para el paciente Los biosimilares son medicamentos seguros y efectivos para el tratamiento de muchas enfermedades, tales como las enfermedades cutáneas e intestinales crónicas (como […]
October 7, 2020

Patient Materials

En Español  Biosimilars are safe and effective medications for treating many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease […]
October 7, 2020

DDT COA #000085: PROMIS® Physical Functioning in Sarcopenia

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)Division of General Endocrinology (DGE) DDT COA NumberDDT COA #000085 Instrument NamePROMIS® Physical Functioning in […]
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