October 8, 2020

Empower Clinic Services, LLC – 516718 – 10/22/2018

Reference #: 3011887629 Product: Drugs Recipient: Recipient Name Arta Shaun Noorian Recipient Title Owner Empower Clinic Services, LLC Empower Clinic Services, LLC 5980 W Sam Houston […]
October 8, 2020

Griffo Botanicals – 610434 – 10/07/2020

Product: Drugs Recipient: Recipient Name Frank Griffo Griffo Botanicals 179 H StreetPetaluma, CA 94952United States [email protected] Date:               October 7, 2020 RE: Unapproved and Misbranded Products […]
October 8, 2020

Prairie Dawn Herbs – 610877 – 10/07/2020

Product: Drugs Date:   October 7, 2020 RE:      Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United […]
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 […]
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