September 18, 2020

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency

Summary Company Announcement Date: September 17, 2020 FDA Publish Date: September 17, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Sub Potency Company Name: […]
September 17, 2020

Scientific Computing Days Posters

A Comprehensive Simulation Analysis of TMB Estimation by Targeted Oncology Panels Dan Li, Binsheng Gong, Yifan Zhang, Joshua Xu [email protected] A General Statistical Framework for Exploring […]
September 16, 2020

What’s New in Regulatory Science

Several times a year the Center for Drug Evaluation and Research sends out an update to share information on new developments, opportunities, and initiatives in regulatory […]
September 16, 2020

Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance

Summary Company Announcement Date: April 11, 2018 FDA Publish Date: April 11, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to a Potential […]
September 16, 2020

Regulatory Education for Industry: Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book – 10/27/2020 – 10/28/2020

On This Page Date: October 27 – 28, 2020 Day1: Tue, Oct 27 8:00 AM – 4:40 PM ET Day2: Wed, Oct 28 8:45 AM – […]
September 15, 2020

6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams

Español Bogus product! Danger! Health fraud alert! You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see […]
September 15, 2020

Coping With Memory Loss

Español Everyone has mild memory lapses from time to time. You can’t find your car keys one day, and your reading glasses go missing the next. […]
September 15, 2020

FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

On August 26, 2020, the Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic […]
September 15, 2020

New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment – 10/15/2020 – 10/16/2020

On This Page Date: October 15 – 16, 2020 Day1: Thu, Oct 15 8:00 AM – 10:30 AM ET Day2: Fri, Oct 16 8:00 AM – […]
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