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July 23, 2020

21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics – 607654 – 07/21/2020

Product: BiologicsDrugsFood & Beverages Recipient: Recipient Name Dr. Phillip Yoo, DC 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics 12665 Garden Grove Blvd, Suite 311Garden […]
July 23, 2020

FDA Proposes New Rule on Reporting Requirements

For Immediate Release: July 23, 2020 Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try […]
July 22, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

Summary Company Announcement Date: July 22, 2020 FDA Publish Date: July 22, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Cross contamination with lidocaine […]
July 22, 2020

FDA In Brief: Findings from Real-World Data Study Reveal Higher Risk of Hospitalization and Death Among Cancer Patients with COVID-19, Underscore Health Disparities

July 22, 2020 Media Inquiries   Kristin Jarrell  301-796-0137 The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, […]
July 22, 2020

Field Science – Laboratory Manual

ORA Laboratory Manual Introduction The Laboratory Manual is a reference manual for ORA laboratory personnel and supporting units. It provides personnel with information on internal policies […]
July 22, 2020

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards – 02/19/2020 – 02/19/2020

On This Page Date: February 19, 2020 Time: 9:00 AM – 4:00 PM ET Organized By: The Food and Drug Administration (FDA) is re-announcing three public […]
July 21, 2020

Drug Trials Snapshots: BYFAVO

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 […]
July 21, 2020

Meetings, Conferences, & Workshops | Drugs

Past Meetings, Conferences, & Workshops  View FDA Archive for past meetings and materials: 2014-2016, 2017-2018 Resources For You Upcoming Meetings Domestic and Virtual link to content […]
July 21, 2020

August 13, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 08/13/2020 – 08/13/2020

On This Page Date: August 13, 2020 Time: 8:00 AM – 5:00 PM ET Center Date Time Location CDER August 13, 2020 8:00 a.m. to 5:00 […]
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